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 3398 of 3526
510(k) clearances, page 3398 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K790960Quantimune T-3 FiaBio-RadCDPClass II
K790848A-Gent Quantichrom T4 11AAbbott MedicalKLIClass II
K790694Britt Lens ComputerBritt Corp., Inc.IYOClass II
K790589Denture-TightDen-Mat Corp.EBPClass II
K790428Mdl-201A & T Dl-201A Pulse GeneratorPacesetter SystemsDXYClass III
K790218Bipolar Lead Adaptor, Model Ba-415Pacesetter SystemsDTDClass II
K790141Pulse Generator, R Wave DemandPacesetter SystemsDXYClass III
K791448Hemodialyzers Rp-510 and Rp-514Hospal Medical Corp.FJGClass II
K791370Silicone Surgical Vessel LoopsConphar, Inc.DWSClass I
K791364Quinton Model 630 and 636 ECG Data CartQuinton, Inc.DPSClass II
K791363Kwik-Awa VestMedical Specialties Inc.DRGClass II
K791351Cement SpacersDepuy, Inc.KYBClass I
K791350Pope Ambulatory Halo VestHospital Products Co.IQFClass I
K791346Disposable BedpanGeneral Clinical Plastics Corp.FOBClass I
K791345Medicine CupGeneral Clinical Plastics Corp.KYWClass I
K791337Taylor Neurological HammerAmdia Medical ProductsGWZClass I
K791336Bucks Neurological HammerAmdia Medical ProductsGWZClass I
K791332Universal Foley Catheter TrayAbco Dealers, Inc.KODClass II
K791331The Tucker-Sach Foot and Tucker-Syme FtKiswood Manufacturing, Inc.ISHClass I
K791308Uldall Subclavian Cannula Sc-100Vas-Cath of Canada, Ltd.FIQClass II
K791307Unipor Breathing Circuit FilterPall Biomedical Products Co.CAHClass II
K791306Ellik EvacuatorDavol, Inc.KQTClass II
K791296Chemetrics Analyzer IIChemetrics Corp.JJEClass I
K791290Beckman B-4 Teb Buffer KitBeckman Instruments, Inc.JBDClass II
K791288Yellow Alert SystemHemoy, Inc.KGXClass I
K791274Rely TamponProcter & Gamble Mfg. Co.HEBClass II
K791270Conphar Leg BagConphar, Inc.KNXClass II
K791269Conphar Stomach Tube-SterileConphar, Inc.KNTClass II
K791268Conphar Rectal Tube-SterileConphar, Inc.KNTClass II
K791264Conphar Nelaton Catheter-SterileConphar, Inc.KODClass II
K791262Conphar Urinary Drainage Bag 2000MlConphar, Inc.KNXClass II
K791257Conphar Feeding Tube-SterileConphar, Inc.KNTClass II
K791256Secutex Surgical BinderConphar, Inc.FQMClass I
K791254Conphar Silicone Drains-SterileConphar, Inc.KDQClass II
K791251Conphar Leg Bag-SterileConphar, Inc.KNXClass II
K791250Conphar Stomach Tube-Sterile-X-RayConphar, Inc.KNTClass II
K791245Conphar External CatheterConphar, Inc.KNXClass II
K791243Lubricating JellyAbco Dealers, Inc.KMJClass I
K791228Para-8Streck Laboratories, Inc.JPKClass II
K791227Para-7Streck Laboratories, Inc.JPKClass II
K791226Platelet-Chex PlusStreck Laboratories, Inc.JPKClass II
K791220Flowmeter, Back Pressure Compensated,Timeter Instrument Corp.CAXClass I
K791211BindafixConphar, Inc.FQMClass I
K791209Ivac 819 Electronic ThermometerYFLLClass II
K791208Ivac 833 Electronic ThermometerYFLLClass II
K791199Anesthesia Oxygen Analyzer Model 101Rule Medical Instruments, Inc.CCLClass II
K791167Dexide Disposable Prep PadDexide, Inc.FRLClass I
K791163Pfizer 0200Fs LocallzerPfizer IncJAKClass II
K791153Acta-Scanner 0220FsPfizer IncJAKClass II
K791152Tco2m Model 818Novametrix Medical Systems, Inc.KLKClass II