Cruxi
FDA record research
The 2021–2025 analysis contains 14 selected substantially-equivalent FDA decisions under primary product code OMB. Use it to compare documented submissions and evidence with your product. A separate 2026 update contains 1 decisions through 2026-09-27. The latest selected decision across the acquired endpoint is dated 2026-06-24. Neither set establishes a suitable predicate or the route for your device. The complete-year window has 14 decisions; the separate all-observed-date count is 42. These denominators describe different date ranges.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
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.
Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user
Compare the proposed indication, user, anatomy, technology and operating principle with this actual scope; record differences and unresolved facts.
§ 882.1400 Electroencephalograph. (a) Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head. (b) Classification. Class II (performance standards).
Read the identification, classification, conditions and referenced limitations in the cited section. A numeric reference match is not a buyer classification or exemption determination.
Historical FDA comparison
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.
There are 14 valid recent date pairs. Distribution summaries require at least 20; older records are not substituted for a current benchmark.
Statistical source: FDA openFDA 510(k) decision dataset. Partition 1 Download the identified records and dates (CSV).
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.
42 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
1 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
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 |
|---|---|---|---|---|
| K260998 ↗Ceribell Neurology Review Software | Ceribell, Inc. | 2026-06-24 | Traditional | 90 |
| K252070 ↗Ceribell Infant Seizure Detection Software | Ceribell, Inc. | 2025-11-21 | Traditional | 143 |
| K252160 ↗Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development, LLC | 2025-10-31 | Traditional | 113 |
| K243743 ↗autoSCORE (V 2.0.0) | Holberg Eeg AS | 2025-04-09 | Traditional | 126 |
| K241589 ↗Ceribell Seizure Detection Software | Ceribell, Inc. | 2025-04-09 | Traditional | 310 |
| K242446 ↗Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development Corporation | 2025-01-22 | Traditional | 159 |
| K241390 ↗NeuroMatch | LVIS Corporation | 2024-11-26 | Traditional | 195 |
| K240408 ↗REMI-AI Rapid Detection Module (REMI-AI RDM) | Epitel, Inc. | 2024-10-17 | Traditional | 251 |
Supporting documents actually acquired
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.
The documents are a bounded sample of acquired summaries, not complete evidence coverage of the cohort.
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 | OMB [1] |
| Generic device category | Automatic Event Detection Software For Full-Montage Electroencephalograph [1] |
| Recorded scope | Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user [1] |
| Recorded class | 2 [1] |
| Regulation | 882.1400 [1] |
| Medical specialty | Neurology [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.
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.
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.
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.
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.
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.
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 936de5f5d47b9293b702fc32512a79173969fb788c74a63d9b91abe73f3b86a5
Mon, 06 Jul 2026 18:51:26 GMT · retrieved 2026-10-06
Source key D02 · snapshot cbf07b16e14ae497bc5179512ab2df4ca66023a050fe3a1fa828baf6e4fee790
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002
Fri, 05 Dec 2025 20:59:38 GMT · retrieved 2026-10-07
Source key D02 · snapshot 029f9142f218e8c6564bd37b7eca1331b183ad20f3aa7ce8f9aead8d2fd59530
Mon, 05 May 2025 10:18:56 GMT · retrieved 2026-10-07
Source key D02 · snapshot 71f04f7b8d21999064a6803b7ae1789cfceff2c70201c087b7400688fc4ce8c2
Thu, 01 Oct 2026 22:01:48 GMT · retrieved 2026-10-06
Source key D04 · snapshot 2fb992918a3879de132b47a33c856da2b3234ee3d96cfd79fab03acf30512496
Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.
Compare FDA 510(k) Submission Services
Find FDA US Agent Services | Compare & Get Quotes · FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment)