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 1782 of 3531
510(k) clearances, page 1782 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K981820NeuromapRadionics, Inc.GZLClass II
K981530Spacelabs Medical 90519 Anesthesia Delivery SystemGE HealthcareBSZClass II
K981277PeriformVerimed Holdings, Inc.HIRClass II
K980278Uresil Vascu-Flo Infusion CatheterUresil, LLCDQYClass II
K983282Omi Occipital Cervical Loop, Model A1089Ohio Medical Instrument Co., Inc.KWPClass II
K983064Impra High Porosity GraftImpra, Inc.DSYClass II
K982944Hem-O-Lock, Model 523935Weck Closure SystemsFZPClass II
K982941Hem-O-Lok Model Numbers 523900, 523970Weck Closure SystemsFZPClass II
K982937Model 580-006 Radiation Therapy Ionization ChamberVictoreen, Inc.LHNClass II
K982544Rich-Mar Us500, Us750, Us1000 Therapeutic Unltrasound DevicesRich-Mar Corp.IMIClass II
K982243Canogen Portable Oxygen Generator Model 615Canogen International, Ltd.CAWClass II
K982010FactsPhilips North America LLCJAKClass II
K974738Astra Tech Implant Dental SystemAstra Tech, Inc.DZEClass II
K983971Cardiac Marker Control Module, Model CccmSiemens Healthcare Diagnostics Inc.JJXClass I
K983894Bausch & Lomb Phoenix (Hilafilcon a) Visibility Tinted Contact LensBausch & Lomb IncorporatedLPLClass II
K983850Dimension Ahdl CalibratorSiemens Healthcare Diagnostics Inc.JITClass II
K983740Is-Anti-Pr3 Igg Elisa Test SystemColumbia Bioscience, Inc.MOBClass II
K983669Optical Tracking System with Surface Matching Module, Model OtsRadionics, Inc.HAWClass II
K983545Quadrant UnibondCavex Holland B.V.KLEClass II
K983465The Aptus (Automated) Application of the Sm/rnp Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for theZeus Scientific LLCLKOClass II
K983464The Aptus (Automated) Application of the Jo-1 Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for theZeus Scientific LLCLLLClass II
K983453Procera Allceram Fusing MaterialNobel Biocare Uas, Inc.EIHClass II
K983426The Aptus (Automated) Application of the Ssa Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the DcZeus Scientific LLCLLLClass II
K983425The Aptus (Automated)application of the Ssb Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the DetZeus Scientific LLCLLLClass II
K983423The Aptus (Automated) Application of the Scl-70 Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for theZeus Scientific LLCLLLClass II
K983422The Aptus (Automated) Applications of the Ds DNA Elisa Test System Linked Immunosorbent Assay(elisa)for the DetZeus Scientific LLCLRMClass II
K983420The Aptus(automated)application of the Sm Elisa Test System.an Enzyme Link Immunosorbent Assay(elisa)for the DetectiooZeus Scientific LLCLKPClass II
K983418The Aptus(automated)application of the Rheumatoid Factor Igm Elisa Test System. an Enzyme Linked Immunosorbent Assay(elZeus Scientific LLCDHRClass II
K983390Is-Anti-Mpo Igg Elisa Test SystemColumbia Bioscience, Inc.MOBClass II
K983388Ontrak Testcup-ErRoche Diagnostic Systems, Inc.DIOClass II
K983378The Aptus (Automated) Application of the Ana Screen Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for.Zeus Scientific LLCLJMClass II
K983376The Aptus (Automated) Applicaton of the Ena Screen Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for SZeus Scientific LLCLLLClass II
K983370Prodigy- 3Sybron Dental Specialties, Inc.EBFClass II
K983358G/k Sfn and Stn Locking NailsHowmedica Corp.HSBClass II
K983271Fracture Risk Assessment Option for Dpx Series Bone DensitometersLunar Corp.KGIClass II
K983269Fracture Risk Assessment Option for Expert-Xl Bone DensitometerLunar Corp.KGIClass II
K983268Modification of Tricyclic Serum Tox Eia AssayDiagnostic Reagents, Inc.LFHClass II
K983262Fracture Risk Assessment Option for Pixi Bone DensitometersLunar Corp.KGIClass II
K983212Abbott Architect TestosteroneAbbott MedicalCDZClass I
K983191Dbest Cocaine Test KitAmeritek, Inc.DIOClass II
K983190Dbest Opiates Test KitAmeritek, Inc.DJGClass II
K983189Dbest Methamphetamines Test KitAmeritek, Inc.LAFClass II
K983188Dbest Tetrahydrocannabinol Test KitAmeritek, Inc.LDJClass II
K983174Ontrak Teststik for Barbiturates, Ontrak Teststik for BenzodiazepinesRoche Diagnostic Systems, Inc.JXMClass II
K983168Avant High Speed Handpiece, Avant Fiber Optic High Speed Handpiece, Model #'S Avant Hs 100 & Avant Hs 200Ora Innovations, Inc.EFBClass I
K983113Besure Plus One-Step Home Ovulation Predictor KitSyntron Bioresearch, Inc.CEPClass I
K983090Acon Midstream Pregnancy TestAcon Laboratories, Inc.LCXClass II
K983087Breathtique Tongue ScraperCustom Medical Arts, Inc.LCNClass I
K983051American Electromedics Race Ca Tympanometer/audiometer with Integral PrinterAmerican Electromedics Corp.ETYClass II
K983049American Electromedics Quik Tymp 1 (Qt1) Tympanometer with Intergral PrinterAmerican Electromedics Corp.ETYClass II