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

Applied Medical — Predicate Candidate Screening

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

122 daysmedian FDA review time

292 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K202818	Voyant Fine Fusion Device (EB230)	Applied Medical	2021-12-16	448	0
K191866	GelPOINT Mini Advanced Access Platform	Applied Medical	2020-04-29	292	0
K122619	EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET	Applied Medical	2012-10-02	35	0
K070865	EXPANDING VASCULAR SHEATH	Applied Medical	2007-10-23	208	0
K003443	SUCTION IRRIGATOR	Applied Medical	2001-02-01	87	0
K002915	FLEXIBLE OCCLUSION SYSTEM	Applied Medical	2001-01-08	112	0
K915826	BIO-POLAR FORCEPS	Applied Medical	1992-06-02	155	0
K911462	SURGICAL TROCAR	Applied Medical	1991-04-22	19	1
K844676	APPLIED GAUZE SPONGE 4X4X8	Applied Medical	1985-04-01	122	0
K844726	GAUZE SPONGE 4X4X12 PLY	Applied Medical	1985-04-01	118	0
K844675	APPLIED GAUZE SPONGE 3X3X12	Applied Medical	1985-04-01	122	0
K844674	APPLIED GAUZE SPONGE 2X2X8 PLY	Applied Medical	1985-04-01	122	0
K844673	APPLIED GAUZE SPONGE 4X4X16 PLY	Applied Medical	1985-04-01	122	0
K844677	APPLIED GAUZE SPONGE 2X2X12	Applied Medical	1985-04-01	122	0

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