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 1672 of 3531
510(k) clearances, page 1672 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K000298Etest MoxifloxacinAb BiodiskJWYClass II
K993592Axiom Multipurpose Wound DrainAxiom Medical, Inc.BSOClass II
K993278Ambu Neonate Silicone ResuscitatorAmbu, Inc.BTMClass II
K991348Ivf 20, Ivf 50, Ivf 500, Ivf 500 Antibiotic Free, Models 2420, 2004, 2501, 2500Vitrolife Sweden ABMQLClass II
K001431Modification to Optical Tracking System (Ots)Radionics, Inc.HAWClass II
K001381Cidex Opa SolutionAdvanced Sterilization ProductsMEDClass II
K001348St/ar St and Arrhythmia SoftwareAgilent Technologies, Inc.MHXClass II
K001339MRI Fastsystem Retractor SystemOmni-Tract Surgical, Div. Minn. Scientific, Inc.GADClass I
K001333Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact Portable Patient Monitor, Agilent NoniAgilent Technologies Deutschland GmbHDSIClass II
K001308Modification to Zymed Telemetry System, Model EasiviewAgilent Technologies, Inc.DQAClass II
K001260Allround 55 LfJ.F. Jelenko & Co., Inc.EJTClass II
K001225Accusign Amp 300, Biosign Amp 300, Status Ds Amp 300, Syva Rapid Test D.a.u.Princeton BioMeditech Corp.DKZClass II
K001224Rx Herculink 14 Biliary Stent System, Models 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100Boston Scientific CorporationFGEClass II
K001222Otw Megalink Sds Billiary Stent System, Models 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1Boston Scientific CorporationFGEClass II
K001115Ultra Catheter SetLyco Enterprises, Inc.LKFClass II
K000932Arachnophlebectomy NeedleAdvanced Medical Products, Inc.GAHClass I
K000812Neuro Scan Medical Systems, Models 302L Medicor (Laboratory) and 302P Advantage 3000 (Portable)Neurosoft LtdIKNClass II
K000799Belmont Unit, Model 2000 SeriesBelmont Equipment Corp.EIAClass I
K000775Heart 2005Aerotel Medical Systems (1998), Ltd.DXHClass II
K0006903M Red Dot Radiolucent Monitoring Electrode with Conductive AdhesiveMinnesota Mining and Mfg. Co.DRXClass II
K000618Scandinavian Ivf Sciences Ab, Thaw-Kit 1Vitrolife AB/Scandinavian Ivf Sciences ABMQLClass II
K000597Vita ResponseVidentEIHClass II
K000563Modification to Envoy Patient MonitorMennen Medical, Inc.MHXClass II
K000556Atac Pak Glucose Reagent and Atac Calibrator KitsElan DiagnosticsCFRClass II
K000530Belleglass Hp EnamelSybron Dental Specialties, Inc.EBFClass II
K000405Intercure Ltd. Respi-LowIntercure, Ltd.HCCClass II
K000155Elecsys Anti-Thyroid Peroxidase Antibody Test SystemRoche Diagnostics GmbHJZOClass II
K000121Immage Immunochemistry System Lipoprotein(a) Lpax Reagent, Array System Lipoprotein(a) Lpa Reagent, Lipoprotein(a) CalibSiemens Healthcare Diagnostics Inc.DFCClass II
K993699The StripperMid-Atlantic Diagnostics, Inc.MQHClass II
K993337Apollo Multi-Racial Reference PopulationNorland Medical Systems, Inc.KGIClass II
K001438Somnus Model S2 Electrosurgical GeneratorSomnus Medical Technologies, Inc.GEIClass II
K001321All-Pro 2010All-Pro Imaging Corp.IXWClass II
K001220Endopath Sureseal Reducer CapEthicon Endo-Surgery IncHETClass II
K001169Optivu Hdvd SystemOptimize, Inc.GCJClass II
K001013Monet Acquisition System for EEG and PolysomnographyAirsep Corp.OLVClass II
K000770Proview Medical Image Display ModuleCerner CorporationLLZClass II
K000693Umeco Optima Multiline Laser SystemMedical Laser SolutionsGEXClass II
K000623Scandinavian Ivf Sciences Ab, Freeze-Kit 1Vitrolife AB/Scandinavian Ivf Sciences ABMQLClass II
K000621Scandinavian Ivf Sciences Ab, Spermrinse -20/100Vitrolife AB/Scandinavian Ivf Sciences ABMQLClass II
K000520C-ItBregas ABCCKClass II
K000303Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Garments for the LimbHealthcare Service and SupplyJOWClass II
K994334Ultra-Flex Hemostasis Introducer. Model 406XxxDaig Corp.DYBClass II
K993760Powdered Latex Examination Gloves with Protein Content Labeling Claim of 200 Micrograms or LessHartalega Sdn BhdLYYClass I
K993732BvblueGryphus Diagnostics, L.L.C.MXBClass I
K001444Steritec Steam Biological Test Pack with Instant Readout Integrator, Model Bi 103Steritec Products, Inc.JOJClass II
K001280Comfit Powder Free Polymer Coated Latex Examination Glove, Non Sterile with Protein Labeling Claim (50 Micrograms or LesWRP Asia Pacific Sdn BhdLYYClass I
K001239Encore Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 Micrograms or Less)Ansell PerryKGOClass I
K001232Non-Sterile Powder-Free Latex Examination Gloves with Protein Labeling Claim 50 Micrograms or LessFitco Dipped Products Pvt., Ltd.LYYClass I
K000928Quinupristin/dalfopristin Antimicrobial Susceptibility Test DiscOxoid, Ltd.JTNClass II
K000926Easyelectrolyte Analyzer and Rapidlyte AnalyzerMedica Corp.CGZClass II