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 1821 of 3531
510(k) clearances, page 1821 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K981185GluAbbott MedicalCFRClass II
K981183Careside GlucoseExigent Diagnostics, Inc.CGAClass II
K981079Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular GraftImpra, Inc.DSYClass II
K981076Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular GraftImpra, Inc.DYFClass II
K981019Quikstrip One Step Phencyclidine (Pcp) TestSyntron Bioresearch, Inc.LCMUnclassified
K980495Muse Cardiovascular Information SystemMarquette Medical Systems, Inc.LOS
K974533TrimportGerard Medical, Inc.LJTClass II
K973924Frios BoneshieldFriatec AGJEYClass II
K973747Controlled Temperature Cabinet SystemSmithLDQ
K973646Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/analyzerBird Products Corp.BZRClass II
K971831Quick Check Instant ThermometerEjb Medical, Inc.FLLClass II
K981267Facts MonoblockDynarad Corp.IZXClass II
K980752XtendWalling Medical Equipment Co.LKYClass II
K980715Autoquant Quantitative Perfusion Spect (Qps) & Quantitative Gated Spect (Qgs)Philips North America LLCKPSClass II
K980684Vr NetserveI.S.G. Technologies, Inc.LMDClass I
K980646Il Synthesis--Addition of Bilirubin as a Measured Parameter for Neonate Whole Blood SamplesInstrumentation Laboratory Co.MQMClass I
K980629Vss, Virtual Simulation SystemNucletron BVIYEClass II
K980567Charger (Ed)Walling Medical Equipment Co.LKYClass II
K980479Quick-Cut Automatic Biopsy SystemGallini U.S., LLCKNWClass II
K980463Spectrum Designs Curvilinear Chin ImplantSpectrum Designs, Inc.FWPClass II
K980462Spectrum Designs Anatomical Chin ImplantSpectrum Designs, Inc.FWPClass II
K980446Spectrum Designs Anterior Chin ImplantSpectrum Designs, Inc.FWPClass II
K980445Spectrum Designs Concave Back Chin ImplantSpectrum Designs, Inc.FWPClass II
K980444Spectrum Designs Bilateral Groove Chin ImplantSpectrum Designs, Inc.FWPClass II
K980308Echotech 3D FreescanEchotech 3D Imaging Systems GmbHIYOClass II
K980246Non-Mydriatic Retinal Camera, Model Cr6-45NmCanon Medical Components U.S.A., Inc.HKIClass II
K973658Diffusion Package / Gyroscan NtPhilips North America LLCLNHClass II
K980594Osteonics Fx-Cablelok Grip ComponentsOsteonics Corp.LYTClass II
K980502Osteonics Total Elbow SystemOsteonics Corp.JDCClass II
K980460Onplant Orthodontic SystemNobel Biocare Uas, Inc.DZEClass II
K980456Jobst Athrombic Pump System 2600Jobst A Beiersdorf Co.JOWClass II
K980428Biomet Biaxial Total ElbowZimmer GmbHJDCClass II
K972020Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc.DXWClass II
K963658Exel Avf Single NeedleExel Intl.FMIClass II
K980827Latex Finger Cot, Powder-Free, with Protein LabelingTucker & AssociatesLZBClass I
K980777Dumex Pak-Its-Absorbasalt Cotton Gauze PackingDumex Medical Surgical Products, Ltd.FROUnclassified
K980703Premilene Nonabsorbable Polypropylene Surgical SutureAesculap IncGAWClass II
K980480Syntec VitmanSyntec, Inc.HQCClass II
K980420LightsheerPalomar Medical Products, Inc.GEXClass II
K980417Medrad Disposable MRI Kit W/check Valve Modelsqk 65V, Medrad MRI Integral T with Check Valve Model Sit 96VMedrad, Inc.LNHClass II
K981382Pasv Dual Lumen Peripherally Inserted Midline Catheter Model Number Midline-NumerousCatheter Innovations, Inc.FOZClass II
K981368Pasv Dual Lumen Peripherally Inserted Central Catheter (Picc) Model Number Pic-NumerousCatheter Innovations, Inc.FOZClass II
K981354Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211Beckman Instruments, Inc.LOJClass II
K981336TbilAbbott MedicalCIGClass II
K981282Elecsys AfpRoche Diagnostics GmbHLOJClass II
K981276N-Assay L D-BilCrestat Diagnostics, Inc.CIGClass II
K981270Irma Blood Analysis SystemDiametrics Medical, Inc.CGZClass II
K981241IronAbbott MedicalJIYClass I
K981218Creatine Kinase (Ck)Abbott MedicalCGSClass II
K981192MgAbbott MedicalJGJClass I