Atlas FDA

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

KEQ — Predicate Candidate Screening

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

28 daysmedian FDA review time
42 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K830515SCOTTS TAP WATER SUBSTITUTE CONCENTRATESurgipath Medical Industries, Inc.1983-03-31420
K792702VASPAR SEALANTMeridian Diagnostics, Inc.1980-01-24280
K792709KOH MOUNTING FLUID W/GLYCEROLMeridian Diagnostics, Inc.1980-01-24280
K792703LACTO-PHENOL ANALINE BLUE FLUIDMeridian Diagnostics, Inc.1980-01-24280
K781868DROPPER, CEPTI-SEAL LAVTOPHENOLMarion Laboratories, Inc.1978-11-22190
K781869DROPPER, CEPTI-SEAL KOH SOLUTIONMarion Laboratories, Inc.1978-11-22190
K781388F.A. MOUNTING MEDIUMFlow Laboratories, Inc.1978-08-21110

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