Atlas FDA

EYQ

56 FDA 510(k) clearances · Product code

56 daysmedian time to decision
138 days90th percentile
56clearances measured

FDA profile

Official device name
Garment, Protective, For Incontinence
Device class
Class I (low risk)
Regulation
21 CFR 876.5920
Medical specialty
Gastroenterology, Urology
Flags
GMP exempt
Adverse events (MAUDE)
2013: 13 · 2014: 11 · 2015: 11 · 2018: 20 · 2019: 28 · 2026: 35
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
DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM (K950784)Advanced Bioresearch Assoc.1995-05-03
KIT PAK INCONTINENT SKIN CARE KIT (K932310)Kit Pak, Inc.1994-06-01
DEODORIZING AND SOUND MUFFLING ANAL PAD (K903342)Biological Resistance, Inc.1990-10-23
LIB SYSTEM, BABY/ADULT DIAPER (K891686)Intera Corp.1989-05-31
INTERA SHIELD AND INTERA UNDERGARMENT (K885185)Intera Corp.1989-02-08
DRIPRIDE PROVIDE SLIM (K883894)Weyerhaeuser Co.1989-01-30
DRIPRIDE ULTRA INCONTINENT PAD (K883895)Weyerhaeuser Co.1989-01-30
REUSABLE ADULT INCONTINENT DIAPER (K883787)Intera Corp.1988-11-07
DRY COMFORT UNDERGARMENT (K882418)Health Tec, Inc.1988-09-29
AT EASE STRESS PAD (K880454)Hospital Specialty Co.1988-06-16
AT EASE ADULT DIAPER (K880455)Hospital Specialty Co.1988-04-14
CHICOPEE ADULT INCONTINENCE SHIELDS (K880338)Chicopee, Inc.1988-03-31
DRIPRIDE PROVIDE ULTRA (K872059)Weyerhaeuser Co.1988-03-16
ATTENDS INCONTINENT BRIEF (K873036)Procter & Gamble Mfg. Co.1988-01-19
MALE URINARY STRESS PAD* (K862877)Convatec, A Division of E.R. Squibb & Sons1986-11-19
FREE & ACTIVE(TM) ABSORBENT PADS (K862878)Convatec, A Division of E.R. Squibb & Sons1986-11-19
MODIFIED PROTECTIVE GARMENT (K861863)Procter & Gamble Mfg. Co.1986-08-11
MATTRESS COVER (K862380)Intera Corp.1986-07-28
MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS (K860598)Procter & Gamble Mfg. Co.1986-03-05
UNITY DISPOSABLE INCONTINENT BRIEF (K860459)Bevan Medical, Inc.1986-02-26
DAISY (ABSORBENT INCONTINENCE SHIELD) (K854730)Lic-Orthion1986-02-06
ADAM (ABSORBENT INCONTINENCE SHIELD) (K854729)Lic-Orthion1986-02-06
DEPEND FITTED BRIEF (K854378)Kimberly-Clark Corp.1985-12-02
ADULT ABSORBENT INCONTINENT BRIEF (K854408)Weyerhaeuser Co.1985-11-19
KAY PLUS ADULT DIAPER (K853740)Beghin_Say Intl., Inc.1985-10-17
PROTECTIVE PAD FOR INCONTINENCE (K853079)I.C.D. Industries, Inc.1985-08-09
ESTEEM INCONTINENT SYSTEM (K852276)Bevan Medical, Inc.1985-08-07
PREFER INCONTINENCE AID (K851876)Rocky Mountain Medical Corp.1985-06-12
ATTENDS INCONTINENT UNDERGARMENT (K850611)Procter & Gamble Mfg. Co.1985-02-26
DIGNITY PANT & ABSORBENT PADS (K850154)Convatec, A Division of E.R. Squibb & Sons1985-02-14
ADULT DISPOS. INCONTINENT PANTS (K850153)Convatec, A Division of E.R. Squibb & Sons1985-02-14
CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH (K845010)Chesebrough-Pond'S U.S.A. Co.1985-01-15
TRANQUILITY (K843869)Principle Business Ent.1984-11-16
MOLINEA INCONTINENT PAD (K843404)Paul Hartmann Corp.1984-10-19
MOLICARE (K843405)Paul Hartmann Corp.1984-10-19
MOLINEA PANTY (K843403)Paul Hartmann Corp.1984-10-19
ULTRA SHIELD BRIEFS (K841953)Ipco Corp.1984-07-19
MINIGARD DISPOSABLE LINERS (K840755)Ipco Corp.1984-04-13
MAXISHIELD INCONTINENCE CARE SYSTEM (K840754)Ipco Corp.1984-04-13
AMBEZE DISPOSABLE INCONTINENCE PANTS (K840753)Ipco Corp.1984-04-13
SERENITY CONTOURED ABSORBENT SHIELDS (K840679)Johnson & Johnson Consumer Products, Inc.1984-03-22
ABSORBENT INCONTINENT PADS & BRIEFS (K834359)Weyerhaeuser Co.1984-03-05
MALE INSERT SLIP (K840482)Beghin_Say Intl., Inc.1984-02-21
ADULT INCONTINENCE BRIEF (K834296)Procter & Gamble Mfg. Co.1984-02-04
ADULT INCONTINENCE PAD (K834295)Procter & Gamble Mfg. Co.1984-02-04
CONVEEN DRIP COLLECTOR/NET PANTS (K832489)Telcam Medical Devices, Inc.1983-09-12
ADULT INCONTINET BRIEF (K821397)Johnson & Johnson Professionals, Inc.1982-05-24
INCONTINENCE PAD OR ADULT DIAPER (K820961)Dafoe & Dafoe, Inc.1982-04-16
INCONTINENT PAD & BELT (K810544)Principle Business Ent.1981-03-11
DISPOSABLE ADULT DIAPER (K790922)Fibre Formations, Inc.1979-07-30
KANGA PANTS (K781901)H.A. & J.E. Wood, Inc.1979-03-06
PANT LINER, DISP. INCONTINENT (K781930)Fibre Formations, Inc.1979-02-01
SUPER-SORBER (K780938)Home Healthcare Products, Inc.1978-12-15
COMFORM ABSORBANT INCONTINENCE PADS (K781375)Kimberly-Clark Corp.1978-09-20
UNDERPAD CODE NO. 8453 (K760277)Johnson & Johnson Professionals, Inc.1976-08-11
UNDERPAD, DISPOSABLE POLYPROPY. (UNILUX) (K760164)Parke-Davis Co.1976-07-20

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