510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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
46,018 of the 176,415 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
20262,618
176,415 records, page 3043 of 3529
510(k) clearances, page 3043 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K841648Diagem Digital Blood Glucose MonitorForward Medical SuppliesJJQClass I
K843817Biotis Martin Lewis AgarOtisville Biotech, Inc.JTYClass II
K843771Biotis Seven H 11 AgarOtisville Biotech, Inc.JSHClass I
K843770Biotis Lysine Iron AgarOtisville Biotech, Inc.
K843769Biotis Lowenstein-Jensen MediaOtisville Biotech, Inc.JSHClass I
K843768Biotis Kligler Iron AgarOtisville Biotech, Inc.JSEClass I
K843767Biotis Urea AgarOtisville Biotech, Inc.JSIClass I
K843766Biotis Mycological Media & SlantOtisville Biotech, Inc.JSJClass I
K843765Biotis Mycobiotic AgarOtisville Biotech, Inc.JSJClass I
K843764Biotis Schaedler Agar & BrothOtisville Biotech, Inc.JSGClass I
K843763Biotis Emb Agar Holt-HarrisOtisville Biotech, Inc.JSIClass I
K843762Biotis Emb-Levine AgarOtisville Biotech, Inc.JSIClass I
K843761Biotis Biggy Agar & Biggy SlantOtisville Biotech, Inc.JSIClass I
K843715Econo MateMountain Medical Equipment, Inc.CAWClass II
K843546Infant Monitor 16900Healthdyne, Inc.BZQClass II
K842596MicropencilSurgical SafetyGEIClass II
K842595MicroelectrodeSurgical SafetyGEIClass II
K843182Master-Chek Bowie-Dick Type TestArvey Corp.JOJClass II
K842708Med. Support Stocking-Venofit LastoflexKundt + Co. AGDWLClass II
K842678i.v. Transfer SpikeLyphomed, Inc.FPAClass II
K84239948 Hour Set ChangesTri-Med, Inc.FPBClass II
K843740Sclavo Chloride TestSclavo, Inc.CHJClass II
K843679Human Serum Cardioactive Drug ControlQuantimetrix Corp.DIFClass I
K843614Corning Immunofixation SysCorning Medical & ScientificCZPClass II
K843610Perspective Chemical AnalyzerAmerican Monitor Corp.JJEClass I
K843605Emit 700 Methaqualone AssaySyva Co.KXSClass II
K843602Breathable Mini-Shield-Private LabelI.C.D. Industries, Inc.HHDClass I
K843592Vico Micro Surgical InstrumentsVisitec Co.HWQClass I
K843570Fiax Haptoglobin Test KitIntl. Diagnostic TechnologyDABClass II
K843565Kova Trol i,ii, III Human Urine-DriedIcl ScientificJJWClass I
K843556Emit D.a.u. Cocaine AssaySyva Co.DIOClass II
K843491Concept Fiber Optic Canaliculus IntubaConcept, Inc.HNLClass I
K843447Cilco Diamond KnifeCilco, Inc.HNNClass I
K843434ISO-Data Centrifuges 1-a, 101, 2D, Etc.Iso-Data, Inc.JQCClass I
K843419Emit 700 Cannabinoid Control SetSyva Co.LASClass I
K843347Rianen Anit-Double Stranded DeoxyribonE.I. Dupont de Nemours & Co., Inc.DHNClass II
K843283Boehringer Mannheim Diagnostics AdamBoehringer Mannheim Corp.JJEClass I
K843197Visitec Eye ShieldVisitec Co.HMPClass I
K843196Visitec Eye SpeculumVisitec Co.HNCClass I
K843195Visitec Flieringa-Legrand Fixation RingVisitec Co.HMHClass I
K843123Frame SpectacleVision Industries Corp.HQZClass I
K843111Roche Reagent for AltRoche Diagnostic Systems, Inc.CKAClass I
K843095Tria Lens SetOptek Medico Co., Ltd.HPCClass I
K843048Ring Supported Trephine for Cornea TransPrecision Instruments, Inc.HRHClass I
K843042Vision TesterStereo Optical Company LLCHKOClass I
K843021Canon 60 Fundus Camera Cf-60UCanon Medical Components U.S.A., Inc.HKIClass II
K843015Sanitary Panty W/pads & DesignedHygienics Industries, Inc.HHDClass I
K842909Liquid Chromatography Columns;ion ExchSupelco, Inc.DPMClass I
K842892Nidek Digital KeratometerNidek, Inc.HQLClass III
K842873Standards & Accessories for Nova InstruDiagnostic Chemicals, Ltd. (USA)JGSClass II