Atlas FDA

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

Precision Cap Systems — Predicate Candidate Screening

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

28 daysmedian FDA review time
35 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K830597BABY CAP, ELECTRODE SET & BOARD ADAPTORPrecision Cap Systems1983-03-24280
K830521PRECISION EEG CAP W/ELECTRODE SET ANDPrecision Cap Systems1983-03-24350
K830598EVOKED POTENTIAL CAP W/EVOKED POTENTIALPrecision Cap Systems1983-03-24280
K830600REFERENCE & MONITORING ELECTRODEPrecision Cap Systems1983-03-24280
K830599LOCALIZING ELECTRODEPrecision Cap Systems1983-03-24280
K830602PRECISION CAP STRAPSPrecision Cap Systems1983-03-24280
K830601FOAMIES DIAPOS. FOAM RUBBER PADSPrecision Cap Systems1983-03-24280

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