Atlas FDA

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

Compumedics Limited — Predicate Candidate Screening

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

184 daysmedian FDA review time
284 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252383Somfit DCompumedics Limited2025-08-28280
K242447Falcon HSTCompumedics Limited2025-02-201880
K231546SomfitCompumedics Limited2023-11-301840
K230073OktiCompumedics Limited2023-02-09300
K191785Orion LifeSpan MEGCompumedics Limited2020-02-142260
K093223COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECGCompumedics Limited2010-01-15940
K072201COMPUMEDICS SOMTE PSG RECORDING SYSTEMCompumedics Limited2008-04-142500
K021176COMPUMEDICS SOMTE SYSTEMCompumedics Limited2003-01-212840
K003175COMPUMEDICS SIESTA SYSTEMCompumedics Limited2000-12-27780

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