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

FXP — Predicate Candidate Screening

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

36 daysmedian FDA review time

295 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days
K971076	PRIMED SHOE COVERS, PRIMED HEAD COVERS	Primeline Medical Products, Inc.	1998-01-13	295
K971191	FAR-EAST SHOE COVERS	Far East Science & Technology Development Co., Ltd.	1997-07-10	101
K970815	CONVERTORS IMPERVIOUS SHOE COVERS	Allegiance Healthcare Corp.	1997-03-27	21
K961342	SHOE COVER, NON-STERILE	Copioumed Intl., Inc.	1996-12-30	285
K955835	FLUID BARRIER BOOT KNEE & ANKLE-HIGH	Instrument Makar, Inc.	1996-11-19	329
K952937	NIOMED NON-SKID SHOE COVERS	Amerasia Corp.	1995-10-23	119
K952897	NIOMED SHOE COVERS	Amerasia Corp.	1995-10-23	122
K943034	OREX SHOE COVERS	Thantex Specialties, Inc.	1995-01-02	189
K932738	KAPPLER PRO/VENT BOOT	Kappler, Inc.	1994-03-29	295
K925815	REUSABLE LIQUIDPROOF BOOTIE	Amsco Sterile Recoveries, Inc.	1993-07-09	234
K914702	STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS	Depuy, Inc.	1993-01-29	469
K913628	DISPOSABLE SHOE COVER	Gem Nonwovews, Inc.	1991-10-04	50
K894383	DISPOSABLE SHOE COVER	American Threshold Industries, Inc.	1989-09-12	57
K893702	TECNOL GAITERS PRODUCT NUMBER 47725-010	Tecnol New Jersey Wound Care, Inc.	1989-06-23	36
K883657	SKID RESISTANT, LONG LASTING SHOE COVERS	James River Corp.	1988-09-15	20
K882280	COVER, SHOE OPERATING ROOM	A Plus International, Inc.	1988-06-23	23
K882128	TECNOL TIGER PAWS PRODUCT NUMBER 47705-010	Tecnol New Jersey Wound Care, Inc.	1988-06-15	26
K880093	CARETEX SKID RESISTANT SHOE COVERS	James River Corp.	1988-01-29	17
K874064	SHOE COVERS	Interpro Intl., Inc.	1987-11-04	30
K872797	NON-SKID SHOE COVERS	Abco Dealers, Inc.	1987-08-04	20
K865023	COVER, SHOE OPERATING ROOM	Ulti-Med Intl., Inc.	1987-01-12	20
K864550	CARETEX SHOE COVERS	James River Corp.	1986-12-24	35
K864026	NONCONDUCTIVE SHOE COVER	Kimberly-Clark Corp.	1986-10-30	15
K862726	DISPOSABLE SHOE COVERS AND NURSES CAPS	Abco Dealers, Inc.	1986-08-01	14
K861528	TECNOL PERSONAL SHOE COVER	Technol, Inc.	1986-05-12	18
K851554	OVERSHOES (SURCHAUSSURES	Roseburg SA	1985-04-30	14
K844705	SHOE COVERS	Medicon, Inc.	1985-01-10	38
K843475	PHARMA-PLAST SINGLE USE OVERSHOES	Zimmar Consulting , Ltd.	1984-10-31	55
K830821	MICRO-MITT	CooperVision, Inc.	1983-04-27	43
K801617	CONDUCTIVE SHOE COVERS	Procter & Gamble Mfg. Co.	1980-08-04	20
K801616	NON-CONDUCTIVE SHOE COVERS	Procter & Gamble Mfg. Co.	1980-08-04	20
K800809	FLARE DIS. CONDUCTIVE&NON. SHOE COVERS	Flare Products, Inc.	1980-05-20	40
K800528	SHIELD PERFECT FIT; DURA-FIT, DISPOS.	American Convertors Div., American Pharmaseal	1980-04-16	40
K780590	SHOE COVERS	Abco Dealers, Inc.	1978-05-09	29
K761072	P.S.M. JUSTA COVER	The Owenby Co.	1976-12-02	16
K760779	BARNER SHOE COVERS & COVERBOOTS	Surgikos, Inc.	1976-11-02	28

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