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 1892 of 3531
510(k) clearances, page 1892 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K971907Calcium ReagentCarolina Liquid ChemistriesCICClass II
K971898Permalute, Try-in PasteUltradent Products Inc.EBFClass II
K971780Thyrotropin(tsh) ElisaMonobind, Inc.JLWClass II
K971711Somnus Model 215 Electrosurgical GeneratorSomnus Medical Technologies, Inc.GEIClass II
K971685Imagescape Digital Retinal Image SystemTomey Corporation USAHKIClass II
K971644CebeSuunto USAHQYClass I
K971639Plustron Ion Toothbrush SystemSAS Group, Inc.MMDClass I
K971483Secure-Wrap (Tm) Sterilization WrapAmerican Threshold Industries, Inc.FRGClass II
K971482Degania Silicone Sil-KDegania Silicone, Inc.MDAClass I
K971453Orthotec K-Cap SystemOrthotech Co., Ltd.HTYClass II
K971193Laseaway Long Pulse and Q-Switched Ruby Laser SystemPolytec Pi, Inc.GEXClass II
K971159Surgical DrapesIntl. Medsurg Connection, Inc.KKXClass II
K971129Oxypure Portable Oxygen GeneratorArbor Research Corp.CAWClass II
K971126Hydrocolloid Wound DressingsInnovative Technologies, Ltd.FROUnclassified
K970918Browne Steam IndicatorBoard of Directors, Albert Browne, Ltd.JOJClass II
K970882Endolight End Irrigating Endo-Illuminator (20 Ga. and 19 Ga.)American Medical Devices, Inc.MPAClass II
K970855Clave ConnectorAbbott MedicalFPAClass II
K970612Sealite Sciences, Inc. Aqualite Ferritin AssaySealite Sciences, Inc.DBFClass II
K970551Quanta Lite B2gpi IggInova Diagnostics, Inc.MSVClass II
K970542Master Neb IIBremed Italia, S.r.l.CAFClass II
K970222Low Protein Latex Examination GlovesKossan Latex Industries (M) Sdn BhdLYYClass I
K970102FilterPromedic, Inc.CAHClass II
K970015Elastyren Powder-Free Patient Examination GlovesEci Medical Technologies, Inc.LZAClass I
K965192Thairapy Vest SystemAmerican Biosystems, Inc.BYIClass II
K965027Vented i.v. SetJms Co., Ltd.FPAClass II
K964974Mouse Anti-Human Cd45, Leucocyte Common Antigen (Lca)/fitc and Cd14, Monocyte/rpeDako Corp.GKZClass II
K964826Powder - Free Latex Examination Gloves ApplicationKossan Latex Industries (M) Sdn BhdLYYClass I
K964595Opus Psa Test SystemBehring Diagnostics, Inc.LTJClass II
K963546Smf Titanium (Ti) Alloy Bone ScrewsSynthes (USA) Products LLCDZLClass II
K962811Spacelabs Medical Multi-Disclosure WorkstationGE HealthcareDXJClass II
K971149Svl-9130 Defibrillation ElectrodeSurvivalink Corp.MKJClass III
K971083ArthroscopeElectro-Biology, Inc.HRXClass II
K970752Spline Engaging Shouldered Abutment SystemSulzer Calcitek, Inc.DZEClass II
K970127Edosseous Dental ImplantSulzer Calcitek, Inc.DZEClass II
K971075Primed Prime-Plus Cotton Gauze SpongesPrimeline Medical Products, Inc.EFQUnclassified
K972033Planmeca IntracamPlanmeca OyEIAClass I
K971909Virgo Ama Elisa KitHemagen Diagnostics, Inc.DBMClass II
K971842Coaxial NeedleUnited States Endoscopy Group, Inc.FCGClass II
K971774Nsk Push-Button Midwest Replacement Turbine:for Quietair and TraditionNsk Nakanishi, Inc.EFBClass I
K971714Ndc Dental System, Version 1.5 X-Ray and VideoNational Data Corp.LLZClass II
K971622Max-I-Probe Endodontic Sealer Delivery SystemMpl Technologies, Inc.KIFClass II
K971621Resistick Solid Laparoscopic ElectrodesApyx Medical CorporationKNFClass II
K971614Quanta Lite RF IgmInova Diagnostics, Inc.DHRClass II
K971324Triglycerides, Tg, or TrigCarolina Liquid ChemistriesCDTClass I
K971296Tondi, Models U-03, U-2M1, U-2M4, Ka-01, Ka-02, Ka-03, Ka-03A, Ka-04, Ka-04A, Ka-05National Hearing Aid Dist., Inc.ESDClass I
K971290Stratasys Fdm Medmodeler SystemPaladin Medical, Inc.LLZClass II
K971246Leo 7000 Quadrature Knee CoilGE Healthcare CoilsMOSClass II
K971245Blink External Eyelid WeightIpax, Inc.MMLClass II
K971072Cholesterol ReagentDerma Media Lab., Inc.CHHClass I
K971055Diffusion Weighted Mr Imaging /Magnetom VisionSiemens Medical Solutions USA, Inc.LNHClass II