Atlas FDA

KME

65 FDA 510(k) clearances · Product code

35 daysmedian time to decision
160 days90th percentile
65clearances measured

FDA profile

Official device name
Bedding, Disposable, Medical
Device class
Class I (low risk)
Regulation
21 CFR 880.6060
Medical specialty
General Hospital
Flags
GMP exempt
Adverse events (MAUDE)
1999: 1 · 2000: 1 · 2008: 3 · 2009: 5 · 2011: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
READY-HEAT BLANKET (K042145)Techtrade, LLC2004-09-17
OREX MEDICAL BEDDING (K944953)Thantex Specialties, Inc.1994-12-02
DISPOSE-A-SHEET (K933636)Belmac Healthcare Corp.1994-01-26
DOCTOR DOWN --RESCUE WRAP (K932539)Three Dog Down1993-11-02
AMERICAN BURN SHEET (K922143)American Silk Sutures, Inc.1992-08-10
FOIL BABY BUNTING (K915303)Gam Industries, Inc.1992-02-20
CHEM-SLEEVE B (K912257)Haz-Med, Inc.1991-12-31
MEDI GUARD PILLOWCASE (K911948)Sancella, Inc.1991-05-28
MEDI GUARD UNDERPAD (K911952)Sancella, Inc.1991-05-28
MEDI GUARD SHEETS/UNDERLAYS (K911953)Sancella, Inc.1991-05-28
MEDI GUARD DRAPES (K911950)Sancella, Inc.1991-05-21
BIO-GUARD SHAVE PREP TRAY (K905003)Network Medical Systems, Inc.1990-12-28
RECEIVING BLANKET (K904274)Anago, Inc.1990-10-26
TRAUMA SLEEVE (K901509)Haz-Med, Inc.1990-09-12
CHEM-SLEEVE (K901629)Haz-Med, Inc.1990-04-27
FLUID SOAKERSHIELD (K900643)Infection Control Products, Inc.1990-04-25
MATTRESS COVER FOR MEDICAL PURPOSES (K896043)Keystone Veterinary Supplies, Inc.1990-01-10
MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE (K891986)Mark One Healthcare Products1989-12-29
DEVON DISPOSABLE HEAD POSITIONER COVER (K894170)Devon Industries, Inc.1989-09-07
BED SHEET, PILLOW CASE (K884380)Saybrex Intl., Inc.1988-11-08
HEADREST, PATIENT COMFORT (K882332)Surgic Aid, Inc.1988-07-19
DRY COMFORT DISPOSABLE UNDERPAD (K881969)Health Tec, Inc.1988-06-07
DRIPRIDE DISPOSABLE UNDERPAD (K881859)Weyerhaeuser Co.1988-06-03
DRIPRIDE DISPOSABLE UNDERPADS (K871725)Weyerhaeuser Co.1987-05-15
PAD, BED LINEN PROTECTIVE (K870925)Quality Disposables, Inc.1987-03-17
DEPEND UNDERPAD (K870522)Kimberly-Clark Corp.1987-03-13
THERMAPAD (K864158)Avail-Southwest Division1987-03-02
KIMLON DISPOSABLE BLANKET (K863179)Kimberly-Clark Corp.1986-08-27
SINGLE-USE PATIENT UNDERPAD (K862348)Procter & Gamble Mfg. Co.1986-07-02
REFLECTIVE BLANKET (K860066)O.R. Concepts, Inc.1986-02-19
ALPHA CHUCK (K853970)Rocky Mountain Medical Corp.1985-11-08
ATTENDS DISPOS. UNDERPAD (K853880)Procter & Gamble Mfg. Co.1985-10-16
MEDICAL, DISPOSABLE BEDDING (K850067)East Texas Lighthouse For the Blind1985-04-19
PAD, PRE-OPERATIVE PREPARATION (K850811)East Texas Lighthouse For the Blind1985-03-21
SHAVE PREP TRAY (K850544)Packaging Technologies, Inc.1985-03-12
WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT (K844196)Biological & Environmental Control Laboratories1984-12-04
SHAVE PREP KITS (K842989)Biological & Environmental Control Laboratories1984-12-04
DISPOSABLE PATIENT BLANKET (K843038)Anago, Inc.1984-10-24
MOLINEA UNDERPADS (K843402)Paul Hartmann Corp.1984-09-07
PILLOW W/STAPHCHEK TICKING (K842335)Monterey Mills, Inc.1984-08-01
DISPOSABLE PILLOW (K842336)Monterey Mills, Inc.1984-07-13
PILLOW COVER, ANTI-MICROBIAL (K832486)American Threshold Industries, Inc.1984-02-13
DRAW SHEET, ANTI-MICROBIAL (K832487)American Threshold Industries, Inc.1984-02-13
SUPER DONUT (K822650)Alimed, Inc.1982-09-30
BARRIER BURN SHEET (K821835)Uhi Corp.1982-07-02
3M THINSULATE DISPOSABLE HOSPITAL BED (K820582)3M Company1982-03-18
NON-ABSORBENT TOWELS (K813519)Cunningham Woodland, Inc.1982-01-05
PATIENT UNDERPAD (K813263)The Buckeye Cellulose Corp.1981-11-27
DISPOSABLE PILLOW (K812079)Carpenter Co.1981-08-04
DISPOSABLE UNDERPADS (K811232)Burina1981-05-21
DISPOSABLE PILLOW (K810264)Anago, Inc.1981-02-09
PATIENT CARE DISPOSABLE INFANT SHIRTS (K802998)American Convertors Div., American Pharmaseal1980-12-22
FLUFF UNDERPAD TYPE UP1001 (K802740)Bio D Corp.1980-12-10
FLUFF UNDERPAD TYPE UP1002 (K802730)Bio D Corp.1980-12-10
STERILIZATION PROCESS/BABY BLANKET (K792626)Procter & Gamble Mfg. Co.1980-01-16
AUTO TRAUMA KIT (K790411)Marshall Electronics, Inc.1979-06-01
INFANT SCALE DISPOSABLE LINER (K790659)Hydro-Med Products, Inc.1979-04-30
PILLOW, CARTER ARM ELEVATION (K790283)Depuy, Inc.1979-04-06
BEDDING, DISPOSABLE HOSPITAL (K781796)Kimberly-Clark Corp.1978-12-07
ROSEALAE (K782001)Asmb1978-12-07
PILLOWS- SINGLE PATIENT USE (K781354)Abco Dealers, Inc.1978-10-17
TOWELS, SHEETS, PILLOWCASES (K781227)Abco Dealers, Inc.1978-10-17
SHEET KIT, STRETCHER, DISPOSABLE (K770486)American Hospital Supply Corp.1977-04-29
TERRYCLOTH BIBS (K761109)Fred Sammons, Inc.1976-12-02
PLASTIC DISPOSABLE BIB (K761108)Fred Sammons, Inc.1976-12-02

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