510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of , the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years
45,902 of the 176,299 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.
Show the numbers
510(k) clearances by decision year, the last 15 years of ingested records
YearClearances
20123,135
20133,052
20143,202
20153,020
20162,956
20173,200
20183,062
20192,918
20202,923
20213,023
20223,209
20233,346
20243,129
20253,225
20262,502
176,299 records, page 3520 of 3526
510(k) clearances, page 3520 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K760306Cards, Giant Face Playing Bk-9419Fred Sammons, Inc.ILTClass I
K760305Balloons, Bk-8112, 8114Fred Sammons, Inc.IONClass I
K760304Canopy, Parachute, Bk-8110Fred Sammons, Inc.IONClass I
K760303Fork, Tuning Bk-7519Fred Sammons, Inc.GWXClass I
K760302Goniometer, Inter. Stand. Large, Bk7514Fred Sammons, Inc.KQWClass I
K760301Goniometer, Med. Inter. Stand. Bk-7512Fred Sammons, Inc.KQWClass I
K760300Padding, Temper Stick Foam, Bk-7175Fred Sammons, Inc.ILHClass I
K760299Strip, Closed Cell Foam, Bk-7171Fred Sammons, Inc.ILHClass I
K760298Support, Wrist, Firm Wire-FoamFred Sammons, Inc.ILHClass I
K760297Carrier, Folding Luggage, Bk-6511Fred Sammons, Inc.
K760296Adjuster, Wheelchair Width, Bk-6470Fred Sammons, Inc.KNOClass I
K760295Carpet Covers for Footrests, Bk-6467Fred Sammons, Inc.KNOClass I
K760294Levers, Door Knob, Bk-6395Fred Sammons, Inc.IKWClass I
K760293Mirror, Extend-a-, Bk-6235Fred Sammons, Inc.ILWClass I
K760292Desk, Beanbag Shuffle, Bk-6059Fred Sammons, Inc.KNOClass I
K760291Holder, Pencil & Crayon, with StandFred Sammons, Inc.ILTClass I
K760290Cane or Crutch Parker (3/4, 7/8, L)Fred Sammons, Inc.KNOClass I
K760289Brush, Disposa-a (Handle, Refill Pkg)Fred Sammons, Inc.ILWClass I
K760288Viewer, Reclining, Bk-4089Fred Sammons, Inc.ILTClass I
K760287Button Aid W/pocket Clip, Bk-2011Fred Sammons, Inc.ILDClass I
K760286Spoon, Soft Food Feeder, Bk-1473Fred Sammons, Inc.ILCClass I
K760285Cone, Hand, Bk-1501Fred Sammons, Inc.ILCClass I
K760284Glass, Nosey Cutout, Bk-1146Fred Sammons, Inc.ILCClass I
K760283Glass, Sip N' Straw with Lid, 1143Fred Sammons, Inc.ILCClass I
K760282Cup Holder/cup,bk-1140Fred Sammons, Inc.ILCClass I
K760281Cup Holder/cup, WheelchairFred Sammons, Inc.ILCClass I
K760223Scanner, Ultrasound Body/heartMediscra, Inc.
K760551Cannula, LarriatLandmark PlasticsCATClass I
K760527T-PadGaymar Industries, Inc.ILOClass II
K760523Monitor ScopeHewlett-Packard Co.DXJClass II
K760519Sunlamp, Flourescent Dermatron F40-313 and F20-313Dermatron Corp.IOBClass II
K760518Adapter, per-Cen-Tox-BodyLandmark PlasticsBYFClass I
K760515Disc Thinner, Will-Cerum LiquidWilliams Gold Refining Co., Inc.
K760514Disc, Will-Cerum LiquidWilliams Gold Refining Co., Inc.
K760512ToothbrushAsset Scientific & Pharmaceutical, Inc.EFWClass I
K760505Solution Administration Set (#2C0631)Travenol Laboratories, S.A.KZDClass I
K760500Tube, Heavy Glass Wall InjectionUnimetrics Corp.DXLClass II
K760489Nebulizer, Handheld (T Up-Draft)Hudson Oxygen Therapy Sales Co.CAFClass II
K760488Airway, Dual ChannelHudson Oxygen Therapy Sales Co.CAEClass I
K760484Stain Set, Histochemical AfbHarleco
K760483Blood-Solution Administration Set, Surg.Travenol Laboratories, S.A.KZDClass I
K760460Schaedler Selective Agar-KvBD Becton Dickinson Vacutainer Systems PreanalyticJSJClass I
K760459Mueller Hinton Agar W/hemoglobinBD Becton Dickinson Vacutainer Systems PreanalyticJSGClass I
K760458Bottle, Blood Culture, SchaedlerBD Becton Dickinson Vacutainer Systems PreanalyticJTWClass I
K760457Schaedler-Selective Agar CnaBD Becton Dickinson Vacutainer Systems PreanalyticJSJClass I
K760007Blood-Smearing Instrument (Miniprep Tm)Geometric Data, Div. Smithkline Corp.GKJClass I
K760359Electrode, Bovie DispersiveNixon, Hargrave, DevansGEIClass II
K760510Monitoring System, RehabilitationMedcraft Corp.DPSClass II
K760509Treadmill, DiagnosticMedcraft Corp.IOLClass I
K760508Accutape 24Medcraft Corp.DSHClass II