Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Brainomix Limited — Predicate Candidate Screening

13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

123 daysmedian FDA review time
245 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260406Brainomix 360 HyperdensityBrainomix Limited2026-06-121230
K251983Brainomix 360 Triage StrokeBrainomix Limited2025-08-26600
K242411Brainomix 360 e-LungBrainomix Limited2025-02-191890
K243294Brainomix 360 e-ASPECTSBrainomix Limited2025-02-141190
K242123Brainomix 360 e-CTABrainomix Limited2025-01-061710
K233875Brainomix 360 e-LungBrainomix Limited2024-05-131580
K232496Brainomix 360 Triage StrokeBrainomix Limited2023-11-21960
K231837Brainomix 360 Triage LVOBrainomix Limited2023-09-28980
K231656Brainomix 360 e-MRIBrainomix Limited2023-08-30840
K231195Brainomix 360 Triage ICHBrainomix Limited2023-07-27910
K223555Brainomix 360 e-CTPBrainomix Limited2023-06-011850
K221564Brainomix 360 e-ASPECTSBrainomix Limited2023-02-232680
K192692Brainomix 360 e-CTABrainomix Limited2020-05-282450

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda