FDA record research

Reduced Ejection Fraction Machine Learning-Based Notification Software (QYE) — FDA decisions, comparisons and evidence

The 2021–2025 analysis contains 5 selected substantially-equivalent FDA decisions under primary product code QYE. Use it to compare documented submissions and evidence with your product. A separate 2026 update contains 0 decisions through 2026-09-27. The latest selected decision across the acquired endpoint is dated 2025-09-19. Neither set establishes a suitable predicate or the route for your device. The complete-year window has 5 decisions; the separate all-observed-date count is 5. 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?

Reduced Ejection Fraction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a reduced ejection fraction for further referral or diagnostic follow-up.

Compare the proposed indication, user, anatomy, technology and operating principle with this actual scope; record differences and unresolved facts.

Cited source

Which current section does the record cite?

§ 870.2380 Cardiovascular machine learning-based notification software. (a) Identification. Cardiovascular machine learning-based notification software employs machine learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up. The software identifies a single condition based on one or more non-invasive physiological inputs as part of routine medical care. It is intended as the basis for further testing and is not intended to provide diagnostic quality output. It is not intended to identify or detect arrhythmias. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be met: (i) Clinical validation must use a test dataset of real-world data acquired from a representative patient population. Data must be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment. The test dataset must be independent from data used in training/development and contain sufficient numbers of cases from important cohorts ( e.g., demographic populations, subsets defined by clinically relevant confounders, comorbidities, and subsets defined by hardware and acquisition characteristics) such that the performance estimates and confidence intervals of the device for these individual subsets can be characterized for the intended use population and acquisition systems ( e.g., acquisition hardware or preprocessing software). Study protocols must include a description of the adjudication process(es) for determining ground truth of training and test datasets; (ii) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output over the full range of inputs; (iii) Performance goals used to determine success of clinical validation must be justified in the context of risks associated with follow-up testing; (iv) Objective performance measures ( e.g., sensitivity, specificity, positive predictive value or negative predictive value) must be reported with relevant descriptive or developmental performance measures. Summary level demographic information and sub-group analyses must be provided for each study site, relevant demographic sub-groups, and acquisition systems; and (v) The test dataset must include a minimum of three geographically diverse sites, separate from sites used in training of the model. (2) Software verification, validation, and hazard analysis must be performed. Software documentation must include: (i) A description of the model/algorithm, algorithm inputs/outputs, and supported patient population; (ii) Integration testing in the intended software system or software environment; and (iii) A description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications, including: (A) A description of input signal/data quality control measures; and (B) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy. (3) Human factors assessment of the intended users in the intended use environment must evaluate the risk of misinterpretation of device output. (4) Labeling must include: (i) A summary of the performance testing methods, tested hardware, tested/supported patient population, results of the performance testing for tested performance measures/metrics, summary-level descriptions of patient demographics and associated subgroup analyses for training and test datasets, and the expected minimum performance of the device; (ii) Device limitations or subpopulations for which the device may not perform as expected; (iii) Warning that the user should not rely on the lack of a suspected finding to rule out follow-up; (iv) A statement that the device output should not replace a full clinical evaluation of the patient and that the output may not be sufficient as the sole basis for further testing; (v) Warnings identifying sensor acquisition factors that may impact measurement results; (vi) Guidance for interpretation of the measurements and typical follow-up testing; and (vii) The type(s) of hardware sensor data used, including specification of compatible sensors for data acquisition. [91 FR 57787, Sept. 11, 2026]

Read the identification, classification, conditions and referenced limitations in the cited section. A numeric reference match is not a buyer classification or exemption determination.

Cited source

Historical FDA comparison

2021–2025: five complete calendar years

Primary code QYE

All statistics in this section use decisions dated 2021-01-01 to 2025-12-31. The partial 2026 update below is excluded from these distributions.

5Selected decisions in these five years

WithheldMedian receipt-to-decision calendar days

5Valid date pairs in the distribution

There are 5 valid recent date pairs. Distribution summaries require at least 20; older records are not substituted for a current benchmark.

20210

20220

20231

20241

20253

Statistical source: FDA openFDA 510(k) decision dataset. Partition 1 Download the identified records and dates (CSV).

Filters, exclusions and reproducible calculation

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.

5 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 3 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.

Official record / device	Recorded applicant	Decision	Recorded type	Calendar days
K250649 ↗Bunkerhill ECG-EF	BunkerHill Health	2025-09-19	Traditional	199
K250652 ↗ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)	Anumana, Inc.	2025-07-28	Traditional	146
K250119 ↗Tempus ECG-Low EF	Tempus AI, Inc.	2025-07-15	Traditional	180
K233409 ↗Eko Low Ejection Fraction Tool (ELEFT)	Eko Health, Inc.	2024-03-28	Traditional	174
K232699 ↗Low Ejection Fraction AI-ECG Algorithm	Anumana, Inc.	2023-09-28	Traditional	23

Supporting documents actually acquired

Go beyond the database row

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.

K250649 · official summary PDF ↗

Term mention: Cybersecurity · PDF page 10 Term occurrence only; read the original passage, including limitations and negation.

K250652 · official summary PDF ↗

Term mention: Software verification · PDF page 7 Term occurrence only; read the original passage, including limitations and negation.

K250119 · official summary PDF ↗

Term mention: Cybersecurity · PDF page 7 Negative or not-applicable wording occurs nearby; read the original passage.
Term mention: Human factors · PDF page 7 Negative or not-applicable wording occurs nearby; read the original passage.
Term mention: Clinical performance · PDF page 7 Term occurrence only; read the original passage, including limitations and negation.
Term mention: Performance testing · PDF page 9 Term occurrence only; read the original passage, including limitations and negation.

The documents are a bounded sample of acquired summaries, not complete evidence coverage of the cohort.

Recorded classification context

Known context: US. Match the intended use and design with the recorded category before treating it as applicable.

Source fact	Recorded value
FDA product code	QYE [1]
Generic device category	Reduced Ejection Fraction Machine Learning-Based Notification Software [1]
Recorded scope	Reduced Ejection Fraction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a reduced ejection fraction for further referral or diagnostic follow-up. [1]
Recorded class	2 [1]
Regulation	870.2380 [1]
Medical specialty	Cardiovascular [1]

Build a comparison that explains the differences

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.
Compare your intended use with a named decision
Choose a named record above. Put your proposed claim beside its actual indications-for-use statement. Record different patients, users, anatomy, settings and output claims; do not treat a shared code as proof of equivalence.
Useful evidence: Your draft indications for use + the selected official summary and its exact page.
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 QYE 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.