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 2058 of 3531
510(k) clearances, page 2058 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K952501Tox Perfect B Tubes and ReagentsChimera Research & Chemical, Inc.DPMClass I
K952468Hi-Line Medical Phacoemulsifier TipHi-Line MedicalHQCClass II
K952303Splash AssistInnovative Outsourcing SolutionsLYUClass I
K952253Enzyme Immunoassay Ena Plus Screening Test KitHelix Diagnostics, Inc.LLLClass II
K951889Lyfo(tm) Differential DiskMicrobiologics, Inc.JTOClass I
K951887Advantage Test StripsBoehringer Mannheim Corp.LFRClass II
K951863Roller ElectrodeOLYMPUS Corporation of the AmericasFASClass II
K951531Swiss Lithoclast LithotripterE.M.S. - Electro Medical Systems SAFFKClass II
K951442FlolabSynectics Medical, Inc.EXYClass II
K951321Radias Neonatal T4 Enzyme ImmunoassayBio-RadKLIClass II
K950898Biobox with Funnel Top (Small, Medium, Large, and X-Large)Biosystems S.A.MMKClass II
K950897Biobox Traptop (Small, Medium, Large and X-Large)Biosystems S.A.MMKClass II
K950290Medi - PumpThomas IndustriesCAFClass II
K950255Argus Hysteroscopy Instrument SystemArgus Medical Co., Inc.HIHClass II
K950153Vented/nonvented Gemini Administration Set with Check Valve and Two Safsite(tm) ValvesImed Corp.FPAClass II
K946265Fibrinogen High Abnormal Control - Level 3Clinical Controls, Inc.GILClass II
K946193Fibrinogen Control (Human) Level 1, 2, 3More Diagnostics Inc.GILClass II
K946095Devilbiss Model 5500Devilbiss Health Care, Inc.CAFClass II
K942326Human C5 Rid KitsJay H. GellerDAYClass II
K941046Vzv Igg Elisa TestGull Laboratories, Inc.LFYClass II
K935589Centra Heart StationMarquette Electronics, Inc.LOS
K930714Sonicaid Model Team Fecg IupOxford Instruments, PLC.HELClass II
K924695Aseptech Portable Ro+ SystemDayton Water SystemsFIPClass II
K953737Vl7600 Rem Patient Return ElectrodeMedtronic, Inc.GEIClass II
K953629Spectacle Sunglasses(non-Prescription)Lowinger Holdings, Inc.HQYClass I
K953550CO2 ArthroflatorKarl Storz Endoscopy-America, Inc.HRXClass II
K9535433M Model 8200P Multipro Bte3M CompanyESDClass I
K953459Acufex Tag AnchorAcufex Microsurgical, Inc.MBIClass II
K953455Opus B12Behring Diagnostics, Inc.CDDClass II
K953132Uimat PumpKarl Storz Endoscopy-America, Inc.BTAClass II
K953063Conceive Ovulation PredictorOrtho-Clinical Diagnostics, Inc.CEPClass I
K952945Aquaflo Hydrogel Wound Dressing & PackerSherwood Medical Co.NAEClass I
K952944Model 445Si-64 & 445Si-42A: Quardrature Wrist CoilMedical Advances, Inc.MOSClass II
K952533Sienet Dicom GatewaySiemens Corp.LMDClass I
K952457Rapid-FoamThe Soule Co., Inc.IYEClass II
K952109Ip500 Nuclear Gamma Camera SystemSiemens Medical Solutions USA, Inc.KPSClass II
K950680Infant Heel WarmerBaxter Healthcare CorporationIMDClass I
K950598Bioresorbable Calcium Phosphate Particles - Bll-GraftBio-Interfaces, Inc.LYCClass II
K950337Karl Storz Stammberger-Sachse Intranasal-FrillKarl Storz Endoscopy-America, Inc.EQJClass I
K946161Dma Total Cholesterol ProcedureData Medical Associates, Inc.CHHClass I
K945779Magnetom Vision (Project 016)Siemens Medical Solutions USA, Inc.LNHClass II
K945439Phonak Piconet 232X-Az Hearing InstrumentPhonak, Inc.ESDClass I
K941198Ebv Lgg Elisa TestGull Laboratories, Inc.LSEClass I
K953050Z33Electone, Inc.ESDClass I
K953047Z20Electone, Inc.ESDClass I
K953031Zeimer Self TonometerCds TechnologiesHKXClass II
K951987Genesis II Total Knee SystemSmith & Nephew Richards, Inc.JWHClass II
K951594Bio-Logic Automatic Event AnalysisBio-Logic Systems Corp.OMBClass II
K950057Tritest Control Reagent Igg1 Fitc/igfg1 Pe/cd45 PercpBecton Dickinson Immunocytometry SystemsGKZClass II
K936024Ultrasound Scanner 2001B & K Medical A/SIYOClass II