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

KAE — Predicate Candidate Screening

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

47 daysmedian FDA review time

91 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K853708	LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE	Downs Surgical , Ltd.	1986-02-14	163
K851795	41-250 TO 41-282 VARIOUS NASAL CUTTING FORCEPS	Artiberia	1985-06-11	47
K851775	19-790 TO 19-1042 DRESSING/SPONGE FORCEPS	Artiberia	1985-06-11	47
K851794	41-180 TO 41-246 VARIOUS NASAL FORCEPS	Artiberia	1985-06-11	47
K833608	GOLD ALLIGATOR FORCEPS	Microtek Medical, Inc.	1984-01-11	91
K833607	MCGEE FORCEPS	Microtek Medical, Inc.	1984-01-03	83
K833605	CUPPED FORCEPS	Microtek Medical, Inc.	1984-01-03	83
K822369	MICRO & MINI-MICRO ALLIGATOR FORCEPS	Treace Medical, Inc.	1982-09-09	34
K822372	OFFICE ECONO-FORCEPS	Treace Medical, Inc.	1982-09-09	34
K812895	YARMO NASAL CARTILAGE SOFTENER	American V. Mueller	1981-11-02	18
K772377	HILDYARD POST NASAL FORCEP	Edward Weck, Inc.	1978-01-17	21
K772397	COTTLE COLUMELLA FORCEP	Edward Weck, Inc.	1978-01-17	21
K772396	ALLIGATOR CUP FORCEPS	Edward Weck, Inc.	1978-01-17	21
K772398	COTTLE LOWER LATERAL FORCEPS	Edward Weck, Inc.	1978-01-17	21

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