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 2432 of 3531
510(k) clearances, page 2432 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K911457Trimedyne Model 1210 Omnipulse Holmium Laser SystTrimedyne, Inc.GEXClass II
K905598Cryptosporidium Antigen DetectionLmd LaboratoriesMHJClass II
K905034Hd-4 Crown & Bridge AlloyHo Dental Co., Inc.EJHClass II
K904446Casf (Tm) (Contoured Anterior Spinal Fixaton Sys.)Acromed Corp.KWQClass II
K901619Wex Multi Domain Cardiac System (Hd-3L)Wex Medical Instrumentation Co.LOS
K913354Kodak Ektascan Storage Phosphor Reader Model 1AEastman Kodak CompanyIXWClass II
K913226Model #810 Stealth-Stim Adult Stimulation PadsCardiotronics, Inc.DRXClass II
K913223Sterile Disposable Urine Collector & AccessoriesMedical Device Inspection CompanyKNXClass II
K913016WarmtouchAdvanced Warming Systems, Inc.DWJClass II
K912844Kodak Ektachem Dtii SystemEastman Kodak CompanyJJEClass I
K912690Augustine Guide(tm) KitAugustine Medical, Inc.BSRClass I
K912667Duoderm Hydroactive Dressing and Cgf DressingsConvatec, A Division of E.R. Squibb & SonsMGQUnclassified
K912531Imd Multicam 1000/2000 Video Camera SystemsInnovative Medical Devices, Inc.FETClass II
K912518Circulon(tm) Adhesive Compression BandageConvatec, A Division of E.R. Squibb & SonsKGXClass I
K911717Adg Intramedullary Bone Plug - VentedAmerican Design Group, Inc.LZNClass II
K911279Dry TimeHealth Sense Intl., Inc.KPNClass II
K910956Compuscan Lt Biometric Ruler and IOL CalculatorStorz Instrument Co.IYOClass II
K910801High Voltage Pulsed Galvanic Stimulation ApplicatiPsychoenergetic Systems, Inc.IPFClass II
K910667Steri-Stat Reusable SyringeDavid Craig Marketing, Inc.FMIClass II
K910279Mcseer/micro Controller Sld St EEG Event RecorderNew England Medical Instruments, Inc.GWQClass II
K904925Infusa Ts Syringe Infusion PumpFerguson MedicalFRNClass II
K904922Infusa D.slt Syringe Infusion PumpFerguson MedicalFRNClass II
K904743Lsi System IIM.S.P., Ltd.LIHClass II
K912507Cpi Model 2215 & Seamed Model 3400Seamed Corp.DTEClass II
K913664Rosys Models 100 and 200Packard Instrument Co., Inc.JQWClass I
K913562Qms - DigoxinSeradyn, Inc.LCSClass II
K913364Scimed 7 Fr. & 8 Fr.Scimed Life Systems, Inc.DQOClass II
K913186Innofluor(tm) Digitoxin Calibrator SetIntl. Bioclinical, Inc.DLJClass II
K912885Kaps 90 Degree Fiberoptic AdaptorJEDMED Instrument CompanyEQHClass I
K912394Transducer ProtectorFiltertek, Inc.FIBClass II
K912249Patient Dose MonitorTheta Systems, Inc.KPZClass II
K911444Rubella Virus Immunological Test SystemWampole LaboratoriesLFXClass II
K910806Metrolab Model 1500Laboratorio Rodriguez Corswant S.r.l.JJQClass I
K910230Lyme-Spot If KitVitek Systems, Inc.LSRClass II
K904962Eye Artificial CustomMidwest Eye Laboratories, Inc.HQHClass I
K904961Artificial Scleral ShellMidwest Eye Laboratories, Inc.HQTClass II
K913552Pin Dot Footrest ProductsPin Dot Products, Inc.KNNClass I
K913544DukkiPin Dot Products, Inc.INMClass I
K913512ImpalaPin Dot Products, Inc.IORClass I
K913373Globalcare ElectrodeGlobalcare Intl., Inc.GXYClass II
K913229Bartels Clostridium Difficile Toxin a Enzym ImmunBaxter Diagnostics, Inc.LLHClass I
K912964Api Uniscept Mic/uniscept Micro-MicAnalytab Products, Inc.JWYClass II
K912792Sharplan Nd:yag Surg.laser,model 3040 SharplaserSharplan Lasers, Inc.GEXClass II
K912263Ha Anatomic Hip Prosth W/ Ti-Nidium Surf Hard ProcZimmer GmbHMEHClass II
K912190Stryker High Vacuum Bone Cement Mixer/inject SystStryker Corp.JDZClass I
K912159Major Set-Up TrayMedical Device Inspection CompanyGCJClass II
K912106Arthroscopy TrayMedical Device Inspection CompanyFSMClass I
K912105Eye TrayMedical Device Inspection CompanyLRPClass I
K911665Escort 300 SeriesMedical Data ElectronicsLDDClass II
K911334Mask, Surgical ApparelThai Hospital Products Co., Ltd.FXXClass II