510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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
46,018 of the 176,415 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
20262,618
176,415 records, page 3032 of 3529
510(k) clearances, page 3032 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K842461Tongue DepressorThe Torrent Corp.FMAClass I
K841809Count-a-Part PlusDiagnostic Technology, Inc.JPKClass II
K844590Power Pack 160 Siemens-Elema AbSiemens Elema ABCBKClass II
K844406Johnson & John Son Ostomy Paste Protectivwe SkinJohnson & Johnson Professionals, Inc.EXBClass I
K844379Stone, Instrument HoningTreace Medical, Inc.
K844320Manual Surgical Instruments for General UseBelgium Surgical Co.
K844131NucleotomeMedical Instrument Development Laboratories, Inc.HSZClass I
K844094Pruitt Irrigation and Occlusion CatheterBionomy, Inc.GBXClass I
K844046United Skin BarriersHowmedica Corp.EXBClass I
K844038Visitec Magnifying SpectaclesVisitec Co.HOIClass I
K843955Extracorporeal Maxima Hollow Fiber OxygenatorExtracorporeal Medical Specialities, Inc.DTZClass II
K843834Bacteriuria Detect. Device Aptek IIApplied Polytechnology, Inc.JXAClass I
K843833Bacteriuria Detect Device, Multi SamplerApplied Polytechnology, Inc.JXAClass I
K843739Cybex Torso Testing & RehabilitationCybexIKKClass II
K843637Health Pulse Fa-222 Transcutaneous Elec. Nerve StiTherapeutic Equipment Corp.GZJClass II
K843583Firm-a-Tron Mark XBiotron, Ltd.IPFClass II
K8435023M Laser Imager3M CompanyLMCClass II
K843385Corometrics 115 Fetal MonitorGE Medical Systems Information Technologies, Inc.HGMClass II
K843219Zimmer Bone Cement Centrifugation SysZimmer GmbHJDZClass I
K843214EpharAkron City HospitalFFIClass II
K843124Q-Scan Thermography SystemQmax Medical, Inc.KXZClass III
K843012Wireguide or GuidewireMedi-Tech, Inc.DQXClass II
K842884Surgeon's GlovesTravenol Laboratories, S.A.KGOClass I
K842777Autofocus Dual Element ProbeTechnicare Corp.IYOClass II
K842543Evoked Potential SysBio-Logic Systems Corp.GWFClass II
K842408Irex 730 Mechanical Sector ScannerIrex Corp.JAFClass II
K842220Multilith 2 Pulse Generator 1141 & 2141Ela Medical, Inc.DXYClass III
K841600CasablancaArcon Corp.HISClass II
K844410Nutribag Mixing Container -2000 MlMedical & Pharmaceutical Supplies, Inc.KPEClass II
K844219Deseret Dentral Line CatheterParke-Davis Co.FOZClass II
K844113Deseret Subclavian Jugular Catheter SetParke-Davis Co.FOZClass II
K844111Derata Medi-Jector IIIDerata Corp.KZEClass II
K843961Color Optic Corneal Eye ShieldColors in Optics Ltd.HOYClass I
K843954Mixing ContainerAmerican McgawKPEClass II
K842754Custom Ultrasonics-Sys 80, 81-24, 83-2Wassenburg Medical B.V.FLGClass I
K840099Model 800-a Veri/pprVeriteGZJClass II
K844322Sgot Reagent SetLivonia Diagnostics, Inc.CIQClass II
K844321Custom LiteBuchmann Optical IndustriesHQGClass I
K844283Sgpt Reagent SetLivonia Diagnostics, Inc.CKDClass I
K844230Rhinomanometer A440 DigitalCenter Laboratories, Inc.BXQClass II
K844217Rich-Mar Delta 330 HvRich-Mar Corp.IMGClass II
K844202Moss Limb Load Monitor Lm101-1Moss Rehabilation HospitalIKEClass I
K844195Biotis Anaerobic Kbe AgarOtisville Biotech, Inc.JSIClass I
K844181Acth RiaSyncor Intl. Corp.CKGClass II
K844167Aria Ht Phenobarbital Radioimmunoassay KitBD Becton Dickinson Vacutainer Systems PreanalyticDKPClass II
K844114Add-1Abbott MedicalJJEClass I
K844107Pharmacia Strep a Direct Swab TestPharmacia, Inc.GTZClass I
K844095Wet Dressing Water-SterileAbsorbent Cotton Co., Inc.NADClass I
K844070Tdx SalicylateAbbott MedicalDKJClass II
K844065Eni Blood Urea Nitrogen ReagentElectro-Nucleonics Laboratories, Inc.CDQClass II