Interoperable Automated Glycemic Controller, Insulin Suspend (QJS) — FDA decisions, comparisons and evidence
The acquired FDA endpoint has no selected substantially-equivalent K-number decisions under primary product code QJS during 2021–2025. Its latest selected record across the endpoint is dated 2020-02-28. Use that dated record only as historical context. Check the recorded scope and current route separately; these data do not provide a recent timing benchmark. The complete-year window has 0 decisions; the separate all-observed-date count is 1. These denominators describe different date ranges.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
Recorded scope and its declared regulatory reference
An exact FDA-record regulation_number match to one acquired Title 21 section. Records with the same normalized scope definition, class, regulation and recorded submission/GMP flags are grouped. Sparse definitions and generic exemption boilerplate do not qualify. No text-similarity equivalence or legal applicability is inferred.
What scope does the FDA record describe?
An interoperable automated glycemic controller, insulin suspend, is a device that temporarily suspend and resumes insulin infusion from a connected infusion pump based on specified thresholds and input glucose levels. Interoperable automated glycemic controllers, insulin suspend, are designed to reliably and securely communicate with digitally connected devices to allow insulin delivery suspension and resumption commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers, insulin suspend, are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.
Compare the proposed indication, user, anatomy, technology and operating principle with this actual scope; record differences and unresolved facts.
§ 862.1356 Interoperable automated glycemic controller. (a) Identification. An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control. (b) Classification. Class II (special controls). The special controls for this device are: (1) Design verification and validation must include: (i) An appropriate, as determined by FDA, clinical implementation strategy, including data demonstrating appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use. (A) The clinical data must be representative of the performance of the device in the intended use population and in clinically relevant use scenarios and sufficient to demonstrate appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use. (B) For devices indicated for use with multiple therapeutic agents for the same therapeutic effect ( e.g., more than one type of insulin), data demonstrating performance with each product or, alternatively, an appropriate, as determined by FDA, clinical justification for why such data are not needed. (C) When determined to be necessary by FDA, the strategy must include postmarket data collection to confirm safe real-world use and monitor for rare adverse events. (ii) Results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use. (iii) A detailed and appropriate, as determined by FDA, strategy to ensure secure and reliable means of data transmission with other intended connected devices. (iv) Specifications that are appropriate, as determined by FDA, for connected devices that shall be eligible to provide input to ( e.g., specification of glucose sensor performance) or accept commands from ( e.g., specifications for drug infusion pump performance) the controller, and a detailed strategy for ensuring that connected devices meet these specifications. (v) Specifications for devices responsible for hosting the controller, and a detailed and appropriate, as determined by FDA, strategy for ensuring that the specifications are met by the hosting devices. (vi) Documentation demonstrating that appropriate, as determined by FDA, measures are in place ( e.g., validated device design features) to ensure that safe therapy is maintained when communication with digitally connected devices is interrupted, lost, or re-established after an interruption. Validation testing results must demonstrate that critical events that occur during a loss of communications ( e.g., commands, device malfunctions, occlusions, etc.) are handled and logged appropriately during and after the interruption to maintain patient safety. (vii) A detailed plan and procedure for assigning postmarket responsibilities including adverse event reporting, complaint handling, and investigations with the manufacturers of devices that are digitally connected to the controller. (2) Design verification and validation documentation must include appropriate design inputs and design outputs that are essential for the proper functioning of the device that have been documented and include the following: (i) Risk control measures to address device system hazards; (ii) Design decisions related to how the risk control measures impact essential performance; and (iii) A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design. (3) The device shall include appropriate, as determined by FDA, and validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following: (i) Secure authentication (pairing) to connected devices; (ii) Secure, accurate, and reliable means of data transmission between the controller and connected devices; (iii) Sharing of necessary state information between the controller and any connected devices ( e.g., battery level, reservoir level, sensor use life, pump status, error conditions); (iv) Ensuring that the controller continues to operate safely when data is received in a manner outside the bounds of the parameters specified; (v) A detailed process and procedures for sharing the controller's interface specification with connected devices and for validating the correct implementation of that protocol; and (vi) A mechanism for updating the controller software, including any software that is required for operation of the controller in a manner that ensures its safety and performance. (4) The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices, and to facilitate the sharing of pertinent information with the responsible parties for those connected devices. Critical events to be stored by the controller must, at a minimum, include: (i) Commands issued by the controller, and associated confirmations the controller receives from digitally connected devices; (ii) Malfunctions of the controller and malfunctions reported to the controller by digitally connected devices ( e.g., infusion pump occlusion, glucose sensor shut down); (iii) Alarms and alerts and associated acknowledgements from the controller as well as those reported to the controller by digitally connected devices; and (iv) Connectivity events ( e.g., establishment or loss of communications). (5) The device must only receive glucose input from devices cleared under § 862.1355 (integrated continuous glucose monitoring system), unless FDA determines an alternate type of glucose input device is designed appropriately to allow the controller to meet the special controls contained within this section. (6) The device must only command drug delivery from devices cleared under § 880.5730 of this chapter (alternate controller enabled infusion pump), unless FDA determines an alternate type of drug infusion pump device is designed appropriately to allow the controller to meet the special controls contained within this section. (7) An appropriate, as determined by FDA, training plan must be established for users and healthcare providers to assure the safety and performance of the device when used. This may include, but not be limited to, training on device contraindications, situations in which the device should not be used, notable differences in device functionality or features compared to similar alternative therapies, and information to help prescribers identify suitable candidate patients, as applicable. (8) The labeling required under § 809.10(b) of this chapter must include: (i) A contraindication for use in pediatric populations except to the extent clinical performance data or other available information demonstrates that it can be safely used in pediatric populations in whole or in part. (ii) A prominent statement identifying any populations for which use of this device has been determined to be unsafe. (iii) A prominent statement identifying by name the therapeutic agents that are compatible with the controller, including their identity and concentration, as appropriate. (iv) The identity of those digitally connected devices with which the controller can be used, including descriptions of the specific system configurations that can be used, per the detailed strategy submitted under paragraph (b)(1)(iii) of this section. (v) A comprehensive description of representative clinical performance in the hands of the intended user, including information specific to use in the pediatric use population, as appropriate. (vi) A comprehensive description of safety of the device, including, for example, the incidence of severe hypoglycemia, diabetic ketoacidosis, and other relevant adverse events observed in a study conducted to satisfy paragraph (b)(1)(i) of this section. (vii) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device. (viii) For any controller with hardware components intended for multiple patient reuse, instructions for safely reprocessing the hardware components between uses. [87 FR 14172, Mar. 14, 2022]
Read the identification, classification, conditions and referenced limitations in the cited section. A numeric reference match is not a buyer classification or exemption determination.
Deduplicate by official submission ID across the complete current manifest partitions. Select exact primary product code, K-number format and the stated SE decision codes with valid dates. Recent distributions use the five complete calendar years preceding the latest valid endpoint decision year. Partial-year counts compare equal January-to-cutoff periods. Quartiles use linear interpolation at (n-1)*p and are withheld below 20 valid date pairs. The analysis n describes only its declared complete-year window; selected_se_n separately counts all selected recorded dates through the cutoff.
1 selected records across all observed dates; 0 other/invalid identifier or decision-date records excluded. 0 missing or invalid date pairs in the five-year window.
Date fields: date_received → decision_date. Quantiles: Hyndman–Fan type 7: linear interpolation at (n − 1) × p; displayed to one decimal; n ≥ 20 valid pairs.
Receipt-to-decision calendar elapsed time includes time outside active FDA review; it is not FDA review time, a promised project timeline or an estimate of future clearance. This selected recorded cohort does not include all applications or establish a success probability, predicate suitability, market size, current market availability or legal authorization for another product.
Calculation fda-buyer-research-3 · database cutoff 2026-09-27. CSV rows identify each official K-number, cohort, date pair, exclusion reason and source version.
Separate partial-year update
2026 decisions through 2026-09-27
0 selected decisions from 2026-01-01 to 2026-09-27. The equivalent previous-year period contains 0 decisions through 2025-09-27. These counts describe the records; they are not market growth or submission success rates.
Named records to investigate
Latest decisions across the database
These dated records may come from 2026 or earlier years. They are a separate investigation list, not the five-year statistical cohort. Compare the actual indications and technology before considering a record as a comparator.
Read the source context, then compare the evidence with your design. Topic locations below are text matches, including possible limitations or negative statements; they are not a mandatory test list.
An interoperable automated glycemic controller, insulin suspend, is a device that temporarily suspend and resumes insulin infusion from a connected infusion pump based on specified thresholds and input glucose levels. Interoperable automated glycemic controllers, insulin suspend, are designed to reliably and securely communicate with digitally connected devices to allow insulin delivery suspension and resumption commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers, insulin suspend, are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control. [1]
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Which specific part of the recorded scope fits or differs?
Put your proposed label and design beside the quoted definition. Record matching facts, differences and missing facts separately; naming the category alone cannot resolve scope.
Useful evidence: Proposed indication/design and a definition-to-product comparison with source locators.
Have the cited section and its limitations been reviewed?
Record the applicable paragraph, conditions and cross-referenced limitations after specialist review. Keep a claimed exemption separate from actual establishment, listing and quality-system responsibilities.
Useful evidence: Dated classification/route rationale and the current provisions relied on, with unresolved conditions.
Separate historical research from a recent comparator
No selected decision falls in the complete-year window. Any named records shown are separately dated historical or current-year research. Obtain their actual indications and assess the current route before using a comparator; the absence of a recent record does not establish an exemption or a route.
Useful evidence: Proposed indication/design, the dated named record if available, and a current route/comparator research rationale.
Explain the technology and evidence differences
For each comparison, record the different materials, hardware, software functions and operating conditions. Link each difference to existing evidence or an unresolved evaluation task.
Useful evidence: A three-column matrix: comparator fact / your design fact / evidence or unresolved gap.
Prepare a scope-based schedule without a sparse timing benchmark
This recent cohort has fewer than 20 valid date pairs, so it supplies no median or percentile benchmark. Ask for a schedule based on actual preparation, evidence gaps, interactions and response assumptions; keep any historical decision context separately dated.
Useful evidence: Document/test readiness, unresolved route/evidence tasks and the assumptions behind the specialist’s proposed sequence.
Work packages and dependencies
Conditional: FDA 510(k) Submission Services — Review the supplied facts and evidence gaps before confirming the service scope.
Optional: Find FDA US Agent Services | Compare & Get Quotes — Include only if your product, actor and delivery needs justify this additional scope. Confirm the responsibility and evidence handoff with the coordinating specialist.
Optional: FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment) — Include only if your product, actor and delivery needs justify this additional scope. Confirm the responsibility and evidence handoff with the coordinating specialist.
What needs to happen first
FDA 510(k) Submission Services → Find FDA US Agent Services | Compare & Get Quotes: Confirm the main product/actor scope and evidence gaps before deciding whether to commission this additional service.
FDA 510(k) Submission Services → FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment): Confirm the main product/actor scope and evidence gaps before deciding whether to commission this additional service.
Questions for providers
Which of the named QJS decisions are actually comparable to our proposed indications and technology, and which would you exclude?
Which evidence differences prevent us from using the comparison yet, and what deliverable resolves each one?
Does your schedule separate submission preparation, testing, FDA interactions and customer response time? What assumptions change it?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
