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

MCY — Predicate Candidate Screening

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

90 daysmedian FDA review time

296 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K970721	DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM	Johnson & Johnson Medical, Inc.	1997-03-21	22	0
K963719	CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE T	Grand Medical Products	1996-11-27	72	0
K960585	WOUND CARE COMPRESSION SYSTEM (WCCS)	Suncoast Medical Products, Inc.	1996-04-26	74	0
K952334	DRESSING CHANGE TRAY	Busse Hospital Disposables, Inc.	1995-07-14	57	0
K951022	CIRCULON SYSTEM STEP 1	Convatec, A Division of E.R. Squibb & Sons	1995-06-12	97	0
K951021	CIRCULON SYSTEM STEP 2	Convatec, A Division of E.R. Squibb & Sons	1995-06-12	97	0
K951476	E-PACK PROCEDURE KITS	ETHICON, Inc.	1995-05-23	54	0
K931932	DRESSING CHANGE TRAY-MODIFIED	Medsurg Industries, Inc.	1993-08-27	130	0
K924690	VARIOUS NON-STERILE CUSTOM TRAYS/KITS	Surgipro Central, Inc.	1993-07-16	302	0
K923905	WOUND DRESSING KIT	Kit Pak, Inc.	1993-07-02	332	0
K925021	TPN TRAY (STERILE)	Customed, Inc.	1993-06-07	256	1
K926063	PER-Q-CATH DRESSING CHANGE TRAY	Gesco Intl., Inc.	1993-06-07	188	0
K921347	CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER	Medi-Flex Hospital Products, Inc.	1993-01-08	296	0
K913480	WOUND CARE TRAY A	Catalina Biomedical Corp.	1991-10-18	73	0
K912116	PRESSURE SORE MANAGEMENT KIT	Medical Device Inspection Co., Inc.	1991-10-18	157	0
K912684	HOME MEDICAL KIT - FOR LITTLE HURTS	Great West Medical Equipment, Inc.	1991-10-15	123	0
K913479	WOUND CARE TRAY B	Catalina Biomedical Corp.	1991-10-08	63	0
K912232	ULCERCARE	Jobst Institute, Inc.	1991-08-14	86	0
K912117	LACERATION TRAY	Medical Device Inspection Co., Inc.	1991-08-09	88	0
K910363	MEGA DRESSING CHANGE KIT	Megadyne Medical Products, Inc.	1991-03-28	58	0
K910011	POST SURGICAL KIT/POST BIOPSY KIT	Dermatological Research Laboratories, Inc.	1991-03-27	84	0
K905123	G-TUBE DRESSING CHANGE TRAY	Continental Medical Laboratories, Inc.	1991-03-27	133	0
K905572	EDLICH WOUND MANAGEMENT TRAY	Sorex Medical	1991-03-12	90	0
K902811	ROUTINE DRESSING TRAY	Orion Life Systems, Inc.	1990-09-25	90	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