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 1708 of 3531
510(k) clearances, page 1708 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K993473Synchron Systems Drug Calibrator 2Siemens Healthcare Diagnostics Inc.DLJClass II
K993425PrimusSiemens Medical Solutions USA, Inc.IYEClass II
K993126Cd-Chex Cd 34Streck Laboratories, Inc.GGLClass II
K993023Synchron Systems Op 300 Low and High Urine ControlsSiemens Healthcare Diagnostics Inc.JJYClass I
K993014Modification to Document Thyroid Cal.verCasco-Nerl Diagnostics Corporation (Maine)JJYClass I
K992965Cordis Webster Fixed Curve Catheters, Models D-1124, D-1085Cordis Webster, Inc.DRFClass II
K992929Dash 3000 Patient MonitorGeneral Electric Medical Systems Information TechnMHXClass II
K992844Hichem Ise Electrolyte BufferElan Holdings, Inc.JGSClass II
K992842Hichem Ise Electrolyte ReferenceElan Holdings, Inc.JGSClass II
K992665Macra Lp(a) Enzyme Immunoassay KitTrinity Biotech USADFCClass II
K991850Safe at-Home Test Kit for Monitoring Hemoglobin AlcBiosafe Laboratories, Inc.LCPClass II
K991105ECG Electrode (Various)ConmedcorpDRXClass II
K990808Pbn DilatorsMedical Device Technologies, Inc.FGEClass II
K990727Syneflash & SyneviewEla Medical, Inc.DQKClass II
K990659Nasal AireBreathing Technologies Corp.BZDClass II
K981914Turbidimetric/nephelometric Human Serum Reference PreparationThe Binding SiteJJXClass I
K993792Smart Vessel Analysis (Smart Va) OptionGE HealthcareJAKClass II
K993791CT Perfusion OptionGE HealthcareJAKClass II
K993648Rotablator Rotational Angioplasty System with the Rotalink Exchangeable CatheterBoston Scientific Corporation Northwest TechnologyMCWClass II
K993637N-395 Pulse Oximeter, with Extended Device ClaimsMedtronic, Inc.DQAClass II
K993618Dxp1000 Holter RecorderBraemar Manufacturing, LLCMWJClass II
K993617Digitrakplus Holter RecorderBraemar Manufacturing, LLCMWJClass II
K993502Powderfree Latex Examination Gloves (Protein Label Claim 50 Micrograms or Less)Besglove Medicare Sdn. Bhd.LYYClass I
K993495Powdered Latex Examination Gloves(protein Label Claim 150 Micrograms or Less)Besglove Medicare Sdn. Bhd.LYYClass I
K993480K-Assay HaptoglobinKamiya Biomedical Company, LLCDADClass II
K993444K-Assay Alpha-1 atKamiya Biomedical Company, LLCDEMClass II
K993441K-Assay Alpha-1 AgKamiya Biomedical Company, LLCLKLClass I
K993437K-Assay C3Kamiya Biomedical Company, LLCCZWClass II
K993360Precinorm Universal Plus and Precipath Universal Plus Control SeraRoche Diagnostics GmbHJJYClass I
K993252Methafilcon a Soft Hydrophilic Contact Lenses, Frequency 55, Frequency 55 UV (to Be Marketed Yr. 2000), Frequency 55 AspCooperVision, Inc.MVNClass II
K993071Puritan-Bennett Ventilator System with Et/tracheostomy Tube Compensation, Tc, Option, Model 840Medtronic, Inc.CBKClass II
K992996Enable Endoscopic Bipolar ScissorsEnable Medical Corp.GEIClass II
K992909HytacEspe Dental AGEBFClass II
K992900Precinorm Universal and Precipath Universal Control SeraRoche Diagnostics GmbHJJYClass I
K992894Meridian Hemodialysis Machine, Model 5M5576Baxter Healthcare CorporationKDIClass II
K992872Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc.LXBClass II
K992834Gem Premier 3000Instrumentation Laboratory Co.CHLClass II
K992710Abbott Architech Glycated Hemoglobin MastercheckAbbott MedicalJJYClass I
K992683Modus 2.5 Mandibular Trauma SetMedartis AGJEYClass II
K992682Modus 2.5 Mandibular Reconstruction SetMedartis AGJEYClass II
K992449Autostat II Anti-Cardiolipin Igm ElisaCogent Diagnotics, Ltd.MIDClass II
K992264Ocular Sciences, Inc., Biomedics 60 (Ocufilcon F) UV Blocking Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc.LPLClass II
K992257New Multiples Reagent StripsBayer Corp.JIRClass I
K991417Abl 735 AnalyzerRadiometer America, IncCHLClass II
K981786Iga Minineph AntiserumThe Binding SiteCFQClass II
K993725Green Chlorinated Powder-Free Latex Examination Gloves with Protein Content Labeling Claim of 50 Micrograms or LessHartalega Sdn BhdLYYClass I
K993723Cardiasure Cardiac Markers ControlQuantimetrix Corp.JJTClass I
K993722Blue Chlorinated Powder Free Latex Examination Gloves with Protein Content Labeling Claim of 50 Micrograms or Less.Hartalega Sdn BhdLYYClass I
K993349Nil, Surgeon's Glove - Powder FreeSri Anusham Rubber Industries Pvt., Ltd.KGOClass I
K993313Comfit Powder Free Blue Nitrile Examination Glove, SterileWRP Asia Pacific Sdn BhdLZAClass I