Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

HCY — Predicate Candidate Screening

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

90 daysmedian FDA review time

146 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K980096	OAC (OPTICAL ASPIRATING CURETTE)	Imagyn Medical Technologies, Inc.	1998-05-01	112	0
K944238	ENDOCYTE TM	D.L. Nelson and Assoc., Inc.	1995-09-15	380	0
K935822	PHASE I CURETTE	Phase I Corp.	1994-04-28	146	0
K901442	BAXTER D & C TRAY	Baxter Healthcare Corp	1990-07-26	121	1
K890384	UTERINE CURETTE	Kinetic Medical Products	1989-02-13	21	0
K881794	IVORY FINDER SET	Ivory Instruments Co.	1988-07-08	73	0
K862297	THE D & C PAD-SAC	Nu-Gyn-Tek, Inc.	1986-07-07	20	0
K850068	LUNE AU CURETTES	Luneau Laboratories	1985-04-08	90	0
K841004	SURGICAL CURETTE, VARIOUS	Premier Dental Products Co.	1984-05-11	63	0
K802313	UTERINE CURETTE	Gynemetrics, Inc.	1981-01-12	111	0
K790032	DISPOSABLE VACUUM CURETTE	British Marketing Ent., Ltd.	1979-02-01	29	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