510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
45,969 of the 176,366 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
20262,569
176,366 records, page 3273 of 3528
510(k) clearances, page 3273 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K812387Digitron Electronic Thermometers - 4700Ercona Corp.FLLClass II
K812376Sheep Blood in Alsever's, Citr., DefibrDutchland Laboratories, Inc.LHTClass I
K812375Baby Chick Blood in Alsever'sDutchland Laboratories, Inc.LHTClass I
K812374Adult Chicken Blood in Alsever's, C., D.Dutchland Laboratories, Inc.LHTClass I
K812373Rabbit Blood in Alsever's, Citr., DefibrDutchland Laboratories, Inc.LHTClass I
K812372Guinea Pig Blood in Alsever's, Cit., DefDutchland Laboratories, Inc.LHTClass I
K812368Rat Blood in Alsever's, CitratedDutchland Laboratories, Inc.LHTClass I
K812367Goose Blood in Alsever's, Citrated (Acd)Dutchland Laboratories, Inc.LHTClass I
K812365Para 1 Sendai HemagglutininDutchland Laboratories, Inc.GQRClass I
K812355Ibm 2991 Blood Cell Processor Mod. 1 & 2Intl. Business MachinesCACClass II
K812339Terufusion Infusion Pump Model Stc-502Terumo Medical Corp.FRNClass II
K812335Trypticase Soy Broth Blood Culture BottFisher Scientific Company L.L.C.JSCClass I
K812280Hematology ControlAmerican DadeJPKClass II
K812242Cordisnhyperion Hemoglobin A1 Test SysCordis US Corp.LCPClass II
K812241Ct/t 9800General Electric Co.JAKClass II
K812237Hemotology Quality Control MixtureAmerican DadeJPKClass II
K812236Gold(au 195) Gamma Camera Check(flood)Amersham Corp.IYOClass II
K812235Gold(au 195) Spot Marker SourcesAmersham Corp.IXDClass I
K812224Pleural Drainage System #Pds-4300Bentley Laboratories, Inc.KDQClass II
K812184Angioscan Spectrum AnalyzerUnigon Industries, Inc.DXKClass II
K812177Life-Tech #1857 Pressure/polot ModuleLife-Tech Instruments, Inc.EXQClass II
K812152Medi ViewMedical SynergyIXCClass I
K812130Spike GuardClinipad Corp.KDJClass II
K811523Plasma FlexTerumo America, Inc.KSRClass II
K812394MRI Gentamicin Ria KitMicroanalytic Research, Inc.DJBClass II
K812386Fetal Bovine Serum - SterileDutchland Laboratories, Inc.KISClass I
K812385Natal Calf (Bovine) Serum - SterileDutchland Laboratories, Inc.KISClass I
K812384Newborn Calf Serum - SterileDutchland Laboratories, Inc.KISClass I
K812383Calf (Bovine) Serum - SterileDutchland Laboratories, Inc.KISClass I
K812382Donor Calf (Bovine-Serum) - SterileDutchland Laboratories, Inc.KISClass I
K812381Donor Horse Serum - SterileDutchland Laboratories, Inc.KISClass I
K812380Rabbit Serum - SterileDutchland Laboratories, Inc.KISClass I
K812379Guinea Pig Serum - SterileDutchland Laboratories, Inc.KISClass I
K812371HemolysinDutchland Laboratories, Inc.
K812370Guinea Pig Complement RegularDutchland Laboratories, Inc.KTQClass I
K812369Guinea Pig Complement Virus AntibodyDutchland Laboratories, Inc.KTQClass I
K812333Cycles Reusable Menstrual PadsCyclesHHDClass I
K812328Scrippsystem Nephelometric Antisera KitScripps-Miles, Inc.DEWClass II
K812305Montg. Esophageal -Salivary Bypass- TubeBoston Medical Products, Inc.KCFClass I
K812302Shiley Fenestrated Low Press. CuffedShiley, Inc.JOHClass II
K812284Zee Electrode-GelZee Medical Products Co., Inc.GYBClass II
K812277Prisma-Fil CompulesCaulk Co., Div. DentsplyEIDClass I
K812272Castle Tec-Test Biological IndicatorSybron Corp.FRCClass II
K812169Visio-FilEspe GmbH (US)EBFClass II
K812120Gingi-Plain Cords & BraidsBelport Co., Inc.JESClass I
K812068Proposed Controls for Dosimetric ReleaseHexcel MedicalLIBClass I
K812051Photolite Aolite Tintomatic LensAmerican Optical Corp.HQGClass I
K812007Legionella Indirect Fluor. AntibodyCenters for Disease Control and PreventionLHLClass II
K812006Legionella Direct Fluorescent AntibodyCenters for Disease Control and PreventionLHLClass II
K811942J & S Iron Saturating ReagentThyroid Diagnostics, Inc.JQFClass I