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 3154 of 3528
510(k) clearances, page 3154 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K837506Kodak T-Mat G Film So-381Eastman Kodak Company
K837499AutosectorTechnicare Corp.
K837443Om-1 Diaphanography Light Transillumination System Sor MammographyMedical Diagnostic Instruments, Inc.
K837440UnknownThe S. S. White Co.
K837422Laser PhotocoagulatorHgm, Inc.
K837413Stretcher Top Tsi-107Therapy Services, Inc.
K831476Nasopharyngeal Airway-Robertazzi StyleFls Medical Products, Inc.BTQClass I
K831266Microsurgical KnifeVxtra Corp.HNNClass I
K831241Laser LaparaxopeEder Instrument Co, Inc.HETClass II
K831083Auto RefractometerNidek, Inc.HKOClass I
K830954Acoh Wellness TesterBradley, Campbell & CarneyBZCClass II
K830911Radial Immunodiffusion PlatesBiocell Laboratories, Inc.DDGClass II
K830738Lensert Contact Lens Cleaning & InsertJermyn Specialties of CaliforniaKYEClass I
K830430Eyelid SpeculumDouglas C. Mckee & Co.HNCClass I
K831918La-Staph Identification SystemIMMY, Inc.JWXClass I
K831576OrthofixElectro-Biology, Inc.JECClass II
K831554Nein Allergen Disc in Vast Ventrex TestVentrex Laboratories, Inc.DHBClass II
K831552Sorbothane Visco Inner Sole PadFred Sammons, Inc.KNPClass I
K831547Raised Toilet Seats & Nail ClippersFred Sammons, Inc.ILSClass I
K831546Adaptive Pens & Lap DeskFred Sammons, Inc.ILPClass I
K831545Reacher & Door OpenerFred Sammons, Inc.IKWClass I
K831540Compressogrip Elastic Stump Shrinker#Fred Sammons, Inc.ILGClass I
K831539Economy Plastic Sock-Bk2084-AidFred Sammons, Inc.ILDClass I
K831538Deluxe Adjust-Angle Board-Bk4066Fred Sammons, Inc.IONClass I
K831509Angiography Kit W/addit. ComponentsMallinckrodt Critical CareDQOClass II
K831488Davron Prof. Scrub Brush-Dry/sterileMinnetonka, Inc.GECClass I
K831469Legionella Cye Agar Base & Bcye SupplOxoid U.S.A., Inc.JSKClass I
K831467Ra-CheckDiagnostic Technology, Inc.DHRClass II
K831465Crp-CheckDiagnostic Technology, Inc.DCNClass II
K831463Ana-CheckDiagnostic Technology, Inc.LKJClass II
K831451Silcath Central Catheter Tray Size-Argon Medical Corp.JCYClass I
K831448Spia Sys for Solid Phase ImmunoassaysR & D Systems, Inc.LIBClass I
K831442Phadebas & Phadezym Rast Allergen DiscsPharmacia, Inc.DHBClass II
K831436Unipolar Atrial J Pacing Lead Model 869Pacesetter SystemsDTBClass III
K831435Ventricular Pacing Leads Models 865/867Pacesetter SystemsDTBClass III
K831426Orthopedic/nalebuff Finger InstrumentsNew England Surgical Instrument Corp.
K831416Emit Qst Tobramycin AssaySyva Co.LCDClass II
K831413Spec IisxMedical Devices Inc.GZJClass II
K831403Low Profile Steerable Balloon DilataAdvanced Cardiovascular Systems, Inc.LITClass II
K831398Linear Enzmatic Uric Acid SystemSimmler IncKNKClass I
K831394SomatronSomatron Co.JFBClass II
K831360Data-Zyme Alkaline Phosphatase ProcedData Medical Associates, Inc.CJEClass II
K831353Astra Systems Enzyme ModuleBeckman Instruments, Inc.CFJClass II
K831345Rianen Prolactin 125I KitNew England NuclearCFTClass I
K831340Drain-R-Drape(eyeSur-Tech, Inc.HMTClass II
K831339Neo-Pregnosticon Duoclon Tube TestOrganon LLCJHJClass II
K831318Compur* M1100 Hematrcrit SystemWorthington Diagnostic SystemsJPIClass II
K831311Solution Admin. Sets W/flashballTravenol Laboratories, S.A.FPAClass II
K831302Pbi Bhcg Ria KitPacific Biotech, Inc.JHIClass II
K831301PEEP System DDraeger, Inc.BYEClass II