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

MMP — Predicate Candidate Screening

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

105 daysmedian FDA review time

517 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K091178	MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN	Mtp Medical Technical Promotion GmbH	2009-07-31	100	0
K043234	LIGHT DRAPE	Wrapped IN Comfort	2005-05-25	184	0
K041501	GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS	Guangzhou Fortunique , Ltd.	2004-11-30	176	0
K040794	INCUBATOR CAPE	Wrapped IN Comfort	2004-06-10	73	0
K032065	MEDLINE BAND BAGS AND EQUIPMENT COVERS	Medline Industries, Inc.	2003-09-22	81	2
K023540	SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09	Valumed	2003-02-04	105	0
K014239	MEDSURG EQUIPMENT COVERS	International Medsurg Connection	2002-02-19	55	0
K970885	ULTRASOUND SYSTEMS DRAPE	Protek Medical Products, Inc.	1997-09-22	195	0
K962288	COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST	Pinnacle Products, Inc.	1997-01-30	230	3
K961699	EQUIPMENT COVERS	United States Surgical, A Division of Tyco Healthc	1996-08-23	113	0
K952241	PROTOUCH OVERGLOVE	Cottrell, Ltd.	1995-08-07	87	0
K931417	STERILE EQUIPMENT COVERS	Custom Medical Products, Ltd.	1995-07-06	836	0
K944198	SURGICAL MICROSCOPE DRAPE	Hydro-Med Products, Inc.	1994-11-27	90	0
K930552	STERILE BARRIER SLEEVE AND COVER	Patient Safety Products, Inc.	1994-07-05	517	0
K820692	BANDBAG, WRAP, STERILE	Contour Fabricators, Inc.	1982-05-03	52	5

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