510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK 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
46,132 of the 176,529 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
20262,732
176,529 records, page 1993 of 3531
510(k) clearances, page 1993 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K960798D & K SunglassesD&K Stores, Inc.HQYClass I
K960414Synergist Power PackChiron Vision Corp.HQCClass II
K960359Aladdin Monitoring Oxygen/air MixerHamilton Medical AGBZRClass II
K960166Percor Stat-Dl 9.5 Fr. 34 & 40CcDatascope Corp.DSPClass II
K960100Spinal Specialties Nerve Block TraySpinal Specialties, Inc.CAZClass II
K955691Serum Volatiles Control Level 1 & 2Clinical Controls, Inc.JJYClass I
K955690Aqueous Ethanol/ammonia Control Level 1, 2, & 3Clinical Controls, Inc.JJYClass I
K955422Axsym N-AcetylprocainamideAbbott MedicalLANClass II
K954710Vapor-Tech Roller Ball Electrode 24 Fr.Northgate Technologies Inc.FASClass II
K951222Total Protein (Urine)Randox Laboratories, LimitedJIRClass I
K961206Opus T3 ControlsBehring Diagnostics, Inc.JJXClass I
K961190Gly-EtchCentrix, Inc.EBCClass II
K961172Dsl Active Non-Extraction Igf-I IrmaDiagnostic Systems Laboratories, Inc.CFLClass I
K961163Lares Research as-1 Lowspeed HandpieceLares ResearchEFBClass I
K961089Pulpdent Endoprep IIPulpdent CorporationEKLClass I
K960824Immunology ControlMedical Analysis Systems, Inc.JJYClass I
K960720Exactech Sterile Modular Drill BitExactech, Inc.HWEClass I
K960579Cynosure Photogenica Vl Cutaneous Vascular Lesion LaserCynosure, LLCGEXClass II
K960535Apollo Total Knee System Single Lug PatellaIntermedics OrthopedicsJWHClass II
K960338Stereotactic Body FrameElekta Instrument ABIYEClass II
K960246Liquid Cardiac Marker 1,2,3 AssayedCiba Corning Diagnostics Corp.JJTClass I
K960233Miniclinic Ovulation PredictorVanguard Biomedical Corp.CEPClass I
K955638Synthafax Aptt ReagentOrtho Diagnostic Systems, Inc.GFOClass II
K955431Rit Liver, Kidney, Stomach Ifa KitThe Binding SiteDBLClass II
K954883Free Flow Safety DeviceSimplivia Healthcare Ltd.FPAClass II
K954824Protector Retractor & Protector Retractor with DrapeMedical Creative Technologies, Inc.KKXClass II
K954683Questlock Acl FixatorWrightmedicaltechnologyincMBIClass II
K952542Ackrad Esophageal Balloon Catheter SetAckrad LaboratoriesBZCClass II
K946281Eclipse 4 ElectrocardiographBurdick Corp.LOS
K940176Ackrad Iui Set for Intrauterine InseminationAckrad LaboratoriesMFDClass II
K960993Pall Sq40s Blood Filter (Sq40s/sq40st)Pall Biomedical Products Co.CAKClass II
K960510TheraviewInfimed, Inc.IYEClass II
K960348Osteograf/n-300 HydroxylapatiteCeramed Corp.LYCClass II
K960323Karl Storz Gelet Uretero-Renoscopes/karl Storz Alken Motion Control DeviceKarl Storz Endoscopy-America, Inc.FGBClass II
K955513Surgical Mask (Non-Sterile)United Medical Ent., Inc.FXXClass II
K954970Stopcock & Luer Lock PlugMedex, Inc.FMGClass II
K9546385 Fr Picc-Line CatheterVygon Corp.LJSClass II
K954564Pid-1 Precision Intelligent DosimeterGammex, Inc.IYEClass II
K954495Pacetrak PlusUniversal Medical, Inc.DXHClass II
K952879Sarns Centrifugal Pump with Duraflo II TreatmentBaxter Healthcare CorporationKFMClass II
K944866Viaspan (Belzer Uw - Css)The Dupont Merck Pharmaceutical Co.KDLClass II
K941567Diathermy Device-MicrofocusCheung Laboratories, Inc.IOAClass II
K961124The NautilusRand Scientific Corp.FZEClass II
K961080Medial Malar ImplantRand Scientific Corp.LZKClass II
K961072Pec ImplantRand Scientific Corp.MICClass II
K961071The Magnum Chin ImplantRand Scientific Corp.FWPClass II
K960949Prosys Bedside Drainage Bag (Sterile) Model 650167Bristol-Myers SquibbKNXClass II
K960703RF-Latex Seiken Reagent SystemGlobe Management Support, Inc.DHRClass II
K960702Crp-Latex Seiken Xr Reagent SystemGlobe Management Support, Inc.DCKClass II
K960450Hebeler Safe-T-TubeBoston Medical Products, Inc.BTRClass II