Atlas FDA

ILS

31 FDA 510(k) clearances · Product code

17 daysmedian time to decision
46 days90th percentile
31clearances measured

FDA profile

Official device name
Adaptor, Hygiene
Device class
Class I (low risk)
Regulation
21 CFR 890.5050
Medical specialty
Physical Medicine
Flags
GMP exempt
Adverse events (MAUDE)
2021: 27 · 2022: 45 · 2023: 59 · 2024: 37 · 2025: 47 · 2026: 524
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MEDICAL TOILET SEAT (K852049)Pedro Aleman1985-06-24
COMMODE CHAIR 98200 (K842651)Guardian Products Co., Inc.1984-08-07
LAVATORY SEAT HEIGHTENER (K830853)Lic-Orthion1983-06-08
RAISED TOILET SEATS & NAIL CLIPPERS (K831547)Fred Sammons, Inc.1983-06-08
TOILET SEAT RAISED (K830425)Maddak, Inc.1983-05-09
SHOWER STOOL W/HANDLES (K830852)Lic-Orthion1983-04-05
BATHING CHAIR FOR CHILD (K823641)Fred Sammons, Inc.1983-01-21
DISPOSABLE TOOTH BRUSH (K823626)Fred Sammons, Inc.1982-12-30
PLASTIC BREAK RESISTANT MIRROR (K823606)Fred Sammons, Inc.1982-12-28
LAVATORY SEAT HEIGHTENER (K823155)Orthion Corp.1982-11-05
COLLAPSABLE LAVATORY HEIGHTENER (K823156)Orthion Corp.1982-11-05
BK-6477 THE DERBY RAISED TOILET SEAT (K821860)Fred Sammons, Inc.1982-07-02
HYGIENE ADAPTORS (K821638)Fred Sammons, Inc.1982-06-11
BATHTUB GRAB BAR (K821009)Guardian Products Co., Inc.1982-04-21
CHILDS TOILET TRAINER HYGIENE AIDS (K813635)Fred Sammons, Inc.1982-01-19
HYGIENE ADAPTORS (K812352)Fred Sammons, Inc.1981-09-14
SECURA BATH SEAT (K812483)Maddak, Inc.1981-09-14
TUBMATE (K811301)American Stair-Glide Corp.1981-05-27
HYGIENE ADAPTORS (K810456)Fred Sammons, Inc.1981-03-04
GARELICK COMMODE (K802511)Garelick Mfg. Co.1980-11-12
TOILET TRAINER FOR HANDICAPPED CHILD (K791423)Kaye Products, Inc.1979-08-10
ANUS STIMULATOR (K790531)Maddak, Inc.1979-04-26
SEMI-RECLINING BATH CHARI & BELT (K790175)Fred Sammons, Inc.1979-02-22
WATER POWERED BATH CHAIR LIFT (K790178)Fred Sammons, Inc.1979-02-08
MOTOR RISER TOLIT LIFT (K781614)Motor Riser Chairs , Ltd.1978-10-03
TOILET AID (K781205)Fred Sammons, Inc.1978-07-31
CONTOURED RAISED TOILET SEAT (K761129)Fred Sammons, Inc.1976-12-02
EXTRA LARGE LONG HANDLED SPONGE (K761126)Fred Sammons, Inc.1976-12-02
LONG HANDLED SPONGE (K761125)Fred Sammons, Inc.1976-12-02
BATHTUB RAILS (K761130)Fred Sammons, Inc.1976-12-02
LONG HANDLED BATH BRUSH (K761127)Fred Sammons, Inc.1976-12-02

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