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 3151 of 3528
510(k) clearances, page 3151 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K831409Haemolyte SolutionDialysis Clinic, Inc.KOCClass II
K831380Delton Light Curing Pit & FissureJohnson & Johnson Professionals, Inc.EBCClass II
K831371Model Fm5Sonicaid, Inc.HGMClass II
K831332Argyle Dual Stage Venous Return Cath.Sherwood Medical Co.DWFClass II
K831295Amylase Reagent #88129Hi Chem, Inc.KHMClass II
K831258Flo-Gard 6100 Volumetric Infusion PumpTravenol Laboratories, S.A.FRNClass II
K831213Specific Gravity InstrumentIrisJREClass I
K831193Scleral PlugMedical Instrument Development Laboratories, Inc.LXPClass II
K831192Infusion CannulaMedical Instrument Development Laboratories, Inc.HMXClass I
K831144Alpha-Stim 2000Electromedical Products, Inc.GZJClass II
K831112Epcom Vcu-1 Vacuum System & CuretteEpcom Medical Systems, Inc.HHIClass II
K831084Sun Photo-KeratoscopeNidek, Inc.HLQClass I
K830971Herpes Simplex Virus Typing ReagentsImmulok, Inc.GQLClass II
K830963Quinidine Reagent Test KitBeckman Instruments, Inc.LBZClass II
K830960Custom in-the-Ear Hearing AidFinetone Hearing InstrumentsESDClass I
K830730Port-a-Cath Implantable Cath. SysPharmacia, Inc.LJTClass II
K830722Sporididin-D Cold Sterilizing/solutionSporicidin Intl.LIFClass II
K830634Cardiotomy FilterTexas Medical Products, Inc.JODClass II
K831806Suture Kits Sterilized W/gama RadiationSouth Mountain MedicalEFQUnclassified
K837605Mv/cm2 Number X74294 Model Number 74229Bio-Tek Instruments, Inc.
K837573Sharplan Laser Positioning SystemLaser Industries, Ltd.
K837515Dental Cassette HoldersXre Corp.
K837465Alcyon Rotational Cobalt TherapyCgr Medical Corp.
K837412Saturne I Linear AcceleratorCgr Medical Corp.
K837355UnknownElscint, Inc.
K837608Pip X-Ray Protective GlassesPinnacle Intl., Inc.
K831548SplintsFred Sammons, Inc.ILHClass I
K837481Bf24 Doppler Model P872 and P874Medasonics, Inc.
K837347Linear Accelerator Therac 25Atomic Energy of CanadaIYEClass II
K837346Model Gammacell 1000Atomic Energy of CanadaMOTUnclassified
K831762Sitz Bath, Single Patient Use #8100Lsl Industries, Inc.KTCClass I
K831716Capd - Catheter AdapterAmerican McgawFKXClass II
K831706Sato Family First Aid KitFood and Drug Service, Inc.ILIClass I
K831690Ipos Anti-Adductus ShoeIpos LuneburgKNPClass I
K831678P-S Medical Csf-Flow Control Valve-BurPudenz-Schulte Medical Research Corp.JXGClass II
K831606Gf-180-L Hollow Fiber HemodialysisGambro, Inc.KOCClass II
K831550Finger Boniometer Bk7506Fred Sammons, Inc.KQWClass I
K831544Deluxe Traction Exercise Glove Bk5035Fred Sammons, Inc.IODClass I
K831543Adjust. Weights-Bk5171-05,10,20 BeokFred Sammons, Inc.IONClass I
K831542Adjustable Polycentric Elbow HingeFred Sammons, Inc.IQIClass I
K831508Malis Cmc-II Bipolar Coagulator & CutValley Forge Scientific Corp.GEIClass II
K831497Spirometrics Breon 2400 & Smi 2400Spirometrics, Inc.BZGClass II
K831372Tls Surgical MarkerPorex MedicalFZZClass I
K831248Patellar Fat Pad RetractorTechmedica, Inc.HRXClass II
K831198CPR Heartsaver and BreatholatorCervco Corp.BTMClass II
K831135Saunders #7080 Cervical Traction SysChattanooga Group, Inc.ILZClass I
K831078Straith Oral AirwaySurgical Technology Laboratories Inc.CAEClass I
K831044Limited Motion Functional Knee BraceMizuho Orthopedic Systems IncITQClass I
K831041Sagittal Knee TesterMizuho Orthopedic Systems IncFTYClass I
K831002Tpg 1000Physical Diagnostics, Inc.KQZClass I