Atlas FDA

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

ILC — Predicate Candidate Screening

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

17 daysmedian FDA review time
47 days90th percentile
32clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K833177GLOSSECTOMY FEEDING SPOONSMaddak, Inc.1983-10-31420
K830854COLLAPSABLE LAVATORY SEAT HEIGHTENERLic-Orthion1983-04-05190
K830851BATH TUB SEAT & BATH BOARDLic-Orthion1983-04-05190
K823594PLASTIC BUILT-UP HANDLE EATING UTENSILSFred Sammons, Inc.1982-12-22160
K821643EATING UTENSILSFred Sammons, Inc.1982-06-1180
K813630BK-1129 BOTTLE STRAWFred Sammons, Inc.1982-01-19210
K812346ALUMINUM SCOOP DISKFred Sammons, Inc.1981-09-11240
K811488FEEDING AID KITFred Sammons, Inc.1981-06-12170
K810455EATING UTENSILSFred Sammons, Inc.1981-03-04130
K801706BK-1426-00-01 STONYBROOK/HI-WALL PLATEFred Sammons, Inc.1980-08-07140
K801705BK-1424 INNER LIP PLATE, CERAMICFred Sammons, Inc.1980-08-07140
K800019BK-1544 BE OK SCOOP DISKFred Sammons, Inc.1980-01-21190
K790170BK-1472 SPATULA SPOONFred Sammons, Inc.1979-02-13180
K781196UTENSILS, WEIGHTEDFred Sammons, Inc.1978-07-31170
K781191SPORKS, PLASTIC, DISP.Fred Sammons, Inc.1978-07-31170
K781193KNIFE, LARGE HANDLEFred Sammons, Inc.1978-07-31170
K781192KNIFE, ROCKER, SLOTTED HANDLEFred Sammons, Inc.1978-07-31170
K771274QUADRIPLEGIC MEAT KNIFEFred Sammons, Inc.1977-07-21380
K770169BEESON AUTOMADDAK FEEDERTechhnilab Instruments, Inc.1977-01-2830
K761112PLASTIC HAND CONEFred Sammons, Inc.1976-12-02130
K761106WEIGHTED FORKFred Sammons, Inc.1976-12-02130
K761113BUILT-UP HANDLE UTENSILSFred Sammons, Inc.1976-12-02130
K761107FOOD GUARDSFred Sammons, Inc.1976-12-02130
K761111SQUARE FOOD GUARDFred Sammons, Inc.1976-12-02130
K761104ADULT SWIVEL FORKFred Sammons, Inc.1976-12-02130
K761105WEIGHTED SPORKFred Sammons, Inc.1976-12-02130
K760282CUP HOLDER/CUP,BK-1140Fred Sammons, Inc.1976-09-08470
K760285CONE, HAND, BK-1501Fred Sammons, Inc.1976-09-08470
K760286SPOON, SOFT FOOD FEEDER, BK-1473Fred Sammons, Inc.1976-09-08470
K760283GLASS, SIP N' STRAW WITH LID, 1143Fred Sammons, Inc.1976-09-08470
K760281CUP HOLDER/CUP, WHEELCHAIRFred Sammons, Inc.1976-09-08470
K760284GLASS, NOSEY CUTOUT, BK-1146Fred Sammons, Inc.1976-09-08470

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