Atlas FDA

ILC

32 FDA 510(k) clearances · Product code

17 daysmedian time to decision
47 days90th percentile
32clearances measured

FDA profile

Official device name
Utensil, Eating
Device class
Class I (low risk)
Regulation
21 CFR 890.5050
Medical specialty
Physical Medicine
Flags
GMP exempt
Adverse events (MAUDE)
1998: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
GLOSSECTOMY FEEDING SPOONS (K833177)Maddak, Inc.1983-10-31
COLLAPSABLE LAVATORY SEAT HEIGHTENER (K830854)Lic-Orthion1983-04-05
BATH TUB SEAT & BATH BOARD (K830851)Lic-Orthion1983-04-05
PLASTIC BUILT-UP HANDLE EATING UTENSILS (K823594)Fred Sammons, Inc.1982-12-22
EATING UTENSILS (K821643)Fred Sammons, Inc.1982-06-11
BK-1129 BOTTLE STRAW (K813630)Fred Sammons, Inc.1982-01-19
ALUMINUM SCOOP DISK (K812346)Fred Sammons, Inc.1981-09-11
FEEDING AID KIT (K811488)Fred Sammons, Inc.1981-06-12
EATING UTENSILS (K810455)Fred Sammons, Inc.1981-03-04
BK-1426-00-01 STONYBROOK/HI-WALL PLATE (K801706)Fred Sammons, Inc.1980-08-07
BK-1424 INNER LIP PLATE, CERAMIC (K801705)Fred Sammons, Inc.1980-08-07
BK-1544 BE OK SCOOP DISK (K800019)Fred Sammons, Inc.1980-01-21
BK-1472 SPATULA SPOON (K790170)Fred Sammons, Inc.1979-02-13
UTENSILS, WEIGHTED (K781196)Fred Sammons, Inc.1978-07-31
SPORKS, PLASTIC, DISP. (K781191)Fred Sammons, Inc.1978-07-31
KNIFE, LARGE HANDLE (K781193)Fred Sammons, Inc.1978-07-31
KNIFE, ROCKER, SLOTTED HANDLE (K781192)Fred Sammons, Inc.1978-07-31
QUADRIPLEGIC MEAT KNIFE (K771274)Fred Sammons, Inc.1977-07-21
BEESON AUTOMADDAK FEEDER (K770169)Techhnilab Instruments, Inc.1977-01-28
PLASTIC HAND CONE (K761112)Fred Sammons, Inc.1976-12-02
WEIGHTED FORK (K761106)Fred Sammons, Inc.1976-12-02
BUILT-UP HANDLE UTENSILS (K761113)Fred Sammons, Inc.1976-12-02
FOOD GUARDS (K761107)Fred Sammons, Inc.1976-12-02
SQUARE FOOD GUARD (K761111)Fred Sammons, Inc.1976-12-02
ADULT SWIVEL FORK (K761104)Fred Sammons, Inc.1976-12-02
WEIGHTED SPORK (K761105)Fred Sammons, Inc.1976-12-02
CUP HOLDER/CUP,BK-1140 (K760282)Fred Sammons, Inc.1976-09-08
CONE, HAND, BK-1501 (K760285)Fred Sammons, Inc.1976-09-08
SPOON, SOFT FOOD FEEDER, BK-1473 (K760286)Fred Sammons, Inc.1976-09-08
GLASS, SIP N' STRAW WITH LID, 1143 (K760283)Fred Sammons, Inc.1976-09-08
CUP HOLDER/CUP, WHEELCHAIR (K760281)Fred Sammons, Inc.1976-09-08
GLASS, NOSEY CUTOUT, BK-1146 (K760284)Fred Sammons, Inc.1976-09-08

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