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

KME — Predicate Candidate Screening

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

35 daysmedian FDA review time

160 days90th percentile

65clearances measured

K-number	Device	Applicant	Decided	Review days
K042145	READY-HEAT BLANKET	Techtrade, LLC	2004-09-17	39
K944953	OREX MEDICAL BEDDING	Thantex Specialties, Inc.	1994-12-02	56
K933636	DISPOSE-A-SHEET	Belmac Healthcare Corp.	1994-01-26	183
K932539	DOCTOR DOWN --RESCUE WRAP	Three Dog Down	1993-11-02	160
K922143	AMERICAN BURN SHEET	American Silk Sutures, Inc.	1992-08-10	96
K915303	FOIL BABY BUNTING	Gam Industries, Inc.	1992-02-20	91
K912257	CHEM-SLEEVE B	Haz-Med, Inc.	1991-12-31	223
K911948	MEDI GUARD PILLOWCASE	Sancella, Inc.	1991-05-28	27
K911952	MEDI GUARD UNDERPAD	Sancella, Inc.	1991-05-28	27
K911953	MEDI GUARD SHEETS/UNDERLAYS	Sancella, Inc.	1991-05-28	27
K911950	MEDI GUARD DRAPES	Sancella, Inc.	1991-05-21	20
K905003	BIO-GUARD SHAVE PREP TRAY	Network Medical Systems, Inc.	1990-12-28	51
K904274	RECEIVING BLANKET	Anago, Inc.	1990-10-26	38
K901509	TRAUMA SLEEVE	Haz-Med, Inc.	1990-09-12	166
K901629	CHEM-SLEEVE	Haz-Med, Inc.	1990-04-27	28
K900643	FLUID SOAKERSHIELD	Infection Control Products, Inc.	1990-04-25	75
K896043	MATTRESS COVER FOR MEDICAL PURPOSES	Keystone Veterinary Supplies, Inc.	1990-01-10	86
K891986	MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE	Mark One Healthcare Products	1989-12-29	276
K894170	DEVON DISPOSABLE HEAD POSITIONER COVER	Devon Industries, Inc.	1989-09-07	84
K884380	BED SHEET, PILLOW CASE	Saybrex Intl., Inc.	1988-11-08	21
K882332	HEADREST, PATIENT COMFORT	Surgic Aid, Inc.	1988-07-19	43
K881969	DRY COMFORT DISPOSABLE UNDERPAD	Health Tec, Inc.	1988-06-07	27
K881859	DRIPRIDE DISPOSABLE UNDERPAD	Weyerhaeuser Co.	1988-06-03	31
K871725	DRIPRIDE DISPOSABLE UNDERPADS	Weyerhaeuser Co.	1987-05-15	11
K870925	PAD, BED LINEN PROTECTIVE	Quality Disposables, Inc.	1987-03-17	8
K870522	DEPEND UNDERPAD	Kimberly-Clark Corp.	1987-03-13	35
K864158	THERMAPAD	Avail-Southwest Division	1987-03-02	130
K863179	KIMLON DISPOSABLE BLANKET	Kimberly-Clark Corp.	1986-08-27	9
K862348	SINGLE-USE PATIENT UNDERPAD	Procter & Gamble Mfg. Co.	1986-07-02	12
K860066	REFLECTIVE BLANKET	O.R. Concepts, Inc.	1986-02-19	44
K853970	ALPHA CHUCK	Rocky Mountain Medical Corp.	1985-11-08	43
K853880	ATTENDS DISPOS. UNDERPAD	Procter & Gamble Mfg. Co.	1985-10-16	28
K850067	MEDICAL, DISPOSABLE BEDDING	East Texas Lighthouse For the Blind	1985-04-19	101
K850811	PAD, PRE-OPERATIVE PREPARATION	East Texas Lighthouse For the Blind	1985-03-21	21
K850544	SHAVE PREP TRAY	Packaging Technologies, Inc.	1985-03-12	28
K844196	WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT	Biological & Environmental Control Laboratories	1984-12-04	35
K842989	SHAVE PREP KITS	Biological & Environmental Control Laboratories	1984-12-04	127
K843038	DISPOSABLE PATIENT BLANKET	Anago, Inc.	1984-10-24	83
K843402	MOLINEA UNDERPADS	Paul Hartmann Corp.	1984-09-07	8
K842335	PILLOW W/STAPHCHEK TICKING	Monterey Mills, Inc.	1984-08-01	49
K842336	DISPOSABLE PILLOW	Monterey Mills, Inc.	1984-07-13	30
K832486	PILLOW COVER, ANTI-MICROBIAL	American Threshold Industries, Inc.	1984-02-13	203
K832487	DRAW SHEET, ANTI-MICROBIAL	American Threshold Industries, Inc.	1984-02-13	203
K822650	SUPER DONUT	Alimed, Inc.	1982-09-30	28
K821835	BARRIER BURN SHEET	Uhi Corp.	1982-07-02	10
K820582	3M THINSULATE DISPOSABLE HOSPITAL BED	3M Company	1982-03-18	14
K813519	NON-ABSORBENT TOWELS	Cunningham Woodland, Inc.	1982-01-05	20
K813263	PATIENT UNDERPAD	The Buckeye Cellulose Corp.	1981-11-27	7
K812079	DISPOSABLE PILLOW	Carpenter Co.	1981-08-04	13
K811232	DISPOSABLE UNDERPADS	Burina	1981-05-21	17

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