510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
45,969 of the 176,366 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
20262,569
176,366 records, page 3069 of 3528
510(k) clearances, page 3069 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K841975Rosette Knife 4MmStainless Mfg., Inc.HTZClass I
K841974Retrograde Knife 4Mm & 5MmStainless Mfg., Inc.HTZClass I
K841973Banana Knife SerratedStainless Mfg., Inc.HTZClass I
K841972Banana Knife - K841969-LabelingStainless Mfg., Inc.HTZClass I
K8419712.5Mm & 4Mm Probe K841969-LabelingStainless Mfg., Inc.HXBClass I
K841970Camelback Handle-K841969-LabelingStainless Mfg., Inc.LXHClass I
K8419696.5Mm Hex HandleStainless Mfg., Inc.LXHClass I
K841855Amer. Med. Optics Argon Laser PhotoAmerican Medical OpticsHQFClass II
K841805Obstetrical DopplerEpcom Medical Systems, Inc.KNGClass II
K841760Woodlyn Classic Instrument StandWoodlyn, Inc.HRJClass I
K841710Mac Lee Vaginal IrrigatorMac Lee Medical ProductsHEDClass I
K841273Accommotrac Vision TrainerBiofeedtrac, Inc.
K841191Microtrakspeciman Id Typing Test ContrSyva Co.GQNClass II
K841099Octopus 500/500ECilco, Inc.HPTClass I
K840955Condylar Prosthesis of Mandible W/headSynthes (USA) Products LLCJEYClass II
K840836Cat 100CooperVision, Inc.HKXClass II
K840747Toco Data Telephone Transmitter Dt100pAdvantage Medical Systems, Inc.HFMClass II
K840495Manual Irrigating/aspirating UnitAlltek, Inc.HQCClass II
K840465Q-Med ElectrodeQmed, Inc.DRXClass II
K834155Universal PackAtlantic Optical Systems, Inc.HQEClass II
K834035Universal Self-Aligning Acetabular ComOrthopedic Equipment Co., Inc.JDIClass II
K842114ConcentractorsAmox Corp.CAWClass II
K842041Pulmonary Function SystemSensor Medics Corp.BZGClass II
K841825Scope LightZinnanti Surgical Instruments, Inc.HIHClass II
K841400Neuro PulseParker Laboratories, Inc.GZJClass II
K841264Babyset Tm & Pac Tm -Pulmonary AssistLife Design Systems, Inc.CAIClass I
K841011Elevator - VariousPremier Dental Products CoEMSClass I
K840953Access ScanheadssAdvanced Technology Laboratories, Inc.IYNClass II
K840909Automated Non-Invasive Pressure ModuleGould, Inc.DXNClass II
K831212EndoscannAxcan Scientific Corp.HFFClass II
K842342Mwi 888 & 666 Double Lumen SubclavianMed-West, Inc.
K841918Sigma Proced. 245 Alkaline PhosphataseSigma Diagnostics, Inc.CJEClass II
K841917Sigms Proced. 228 UV Lactate DehydroSigma Diagnostics, Inc.CFJClass II
K841903Fraser Harlake Emerg. Care Suction SysFraser Harlake, Inc.BTAClass II
K841890Varian 2000 Liquid Chromatography AnalyVarian Assoc., Inc.KZRClass I
K841783Blood Gas Control, Level I(acidosisBionostics, Inc.JJSClass I
K841507Foster 757 ScavengerColson Equipment, Inc.CBNClass II
K841478Rianen Cyclic-Amp RadioimmunoassayNew England NuclearCHOClass II
K841381Digital Sphygmomanometer Ua-273Promedical Industries, Inc.DXNClass II
K841380Digital Sphygmomanometer Ua-254Promedical Industries, Inc.DXNClass II
K841266Montgomery Tracheal T-TubeE. Benson Hood Laboratories, Inc.BTOClass II
K841114Allo-Type Human Immunoglobulin-Immucor GTI Diagnostics, Inc.DGXClass I
K840064Urea Nitrogen Reagent SetSterling Biochemical, Inc.CDQClass II
K841863Mono-TecMedilab Corp.KTNClass II
K841862Immu-TecMedilab Corp.DCKClass II
K841587Central Venous Access Catheter Cvac-XxGish Biomedical, Inc.DQYClass II
K840787Craftmatic Electric Adjustable BedContour, Inc.LLIClass II
K840763Silvertorque Cardiac CathetersSurgimed Corp.DQOClass II
K833636Ortho* Serum Elisa Test SystemOrtho Diagnostic Systems, Inc.DAKClass II
K842115Spungard & Surg. Drapes-Gowns & PacksKimberly-Clark CorporationKKXClass II