Atlas FDA

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

KNO — Predicate Candidate Screening

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

17 daysmedian FDA review time
47 days90th percentile
35clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K870298REDMAN ACCESSORIESRedman, Inc.1987-02-26290
K823646FRICTION FEEDERFred Sammons, Inc.1983-01-21460
K823645VELCRO STRAPS TO HOLD ARM TO WHEELCHAIRFred Sammons, Inc.1983-01-21460
K823816WHEELCHAIR PATIENT RESTRAINTSDanek Medical, Inc.1983-01-14280
K823636ARM THROUGH FOR WHEELCHAIR BK-6459-01 &Fred Sammons, Inc.1982-12-28220
K823635CUSHIONS FOR WHEELCHAIR ARMSFred Sammons, Inc.1982-12-28220
K823596CLAMP ON HOLDER FOR A GLASS OR CUPFred Sammons, Inc.1982-12-22160
K823595HEAD SUPPORT FOR WHEELCHAIRFred Sammons, Inc.1982-12-22160
K821642WHEEL CHAIR ACCESSORIESFred Sammons, Inc.1982-06-1180
K820964WHEELCHAIR PALPryor Products1982-04-16100
K813627BK-6453 RIMMED ACRYLIC LAP TRAY KITFred Sammons, Inc.1982-01-19210
K812350WHEELCHAIR ACCESSORIESFred Sammons, Inc.1981-09-11240
K811482INCONTINENT PADFred Sammons, Inc.1981-08-25910
K811486WHEELCHAIR RAMPSFred Sammons, Inc.1981-06-16210
K811491WHEELCHAIR ACCESSORIESFred Sammons, Inc.1981-06-12170
K810448WHEELCHAIR ACCESSORIESFred Sammons, Inc.1981-03-04130
K810439BODY STRAPFred Sammons, Inc.1981-03-04130
K801709BK-5058-01 QUAD-QUIP WHEELCHAIR CUFFFred Sammons, Inc.1980-08-07140
K801489EZ ON SAFETY PONCHOSkil-Care Corp.1980-07-14180
K801214HAMILTON TUCKAWAY DESKOrthopedic Systems, Inc.1980-05-30100
K800208SKIL-CARE LEG PADSSkil-Care Corp.1980-02-21200
K790176ADJUSTABLE HEIGHT DESK ARM LAP TRAY KITFred Sammons, Inc.1979-02-08130
K790177ASHTRAY FOR WHEELCHAIRFred Sammons, Inc.1979-02-08130
K781195BAG, WALDERFred Sammons, Inc.1978-07-31170
K781194BAG, WHEELCHAIRFred Sammons, Inc.1978-07-31170
K781202VEST, SUPPORT, TRUNKFred Sammons, Inc.1978-07-31170
K781203TRAY, LAP, MOLDEDFred Sammons, Inc.1978-07-31170
K780195WHEELCHAIR MUFFOrthopedic Equipment Co., Inc.1978-03-09340
K780191STRAP, LEGRESTOrthopedic Equipment Co., Inc.1978-02-14110
K780194TOE LOOPSOrthopedic Equipment Co., Inc.1978-02-14110
K780193HEEL LOOPSOrthopedic Equipment Co., Inc.1978-02-14110
K760290CANE OR CRUTCH PARKER (3/4, 7/8, L)Fred Sammons, Inc.1976-09-08470
K760292DESK, BEANBAG SHUFFLE, BK-6059Fred Sammons, Inc.1976-09-08470
K760295CARPET COVERS FOR FOOTRESTS, BK-6467Fred Sammons, Inc.1976-09-08470
K760296ADJUSTER, WHEELCHAIR WIDTH, BK-6470Fred 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