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 3141 of 3528
510(k) clearances, page 3141 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K832167Corpak Vtr 300 Enternal PumpCorpak Co.FRNClass II
K832166Flo-Gard 8500 Microinfusion PumpTravenol Laboratories, S.A.FRNClass II
K832159Unitized Enzymatic Glucose Test SetStanbio LaboratoryCGAClass II
K832158Cholesterol High Performance-KBoehringer Mannheim Corp.CHHClass I
K832154Dhea-Sulfate I Ria KitDiagnostic Systems Laboratories, Inc.JKCClass I
K832146Ta-400 Temp. Feedback DeviceSpectral Data SystemsHCCClass II
K832135A.m.s. Temp. Scan 300Andon Medical Systems, Inc.FLLClass II
K832085LensometerCooperVision, Inc.
K832084Evoked 3500 Potential SystemTracor Northern, Inc.GWEClass II
K832037InspireaseKey Pharmaceuticals, Inc.CCQClass I
K831800Texas Interface Pressure Evaluator-TipeTee-Kay Applied TechnologyJFCClass I
K831794Sets & TraysI M, Inc.
K831773Mai Hydroseal Implant for Scleral BuckBcd Products, Inc.HQJClass II
K831771Implantable Program. Cardiac Pulse GenTelectronics, Inc.DXYClass III
K831725Foil in 3 Forms-Non-Sterile SheetsS. Jackson, Inc.FTMClass II
K831668Continu-Flo Solution AdministrationTravenol Laboratories, S.A.FPBClass II
K831648Anchor Brand Surgical NeedlesAnchor Products Co.GABClass I
K831143P.c.a. Unicompartmental Knee ProsthesHowmedica Corp.HRYClass II
K830656Ambulatory Mark III Infusion DeviceWindsor Medical, Inc.FRNClass II
K830340Fitkit I Checkup KitBoditestorCDMClass I
K821799Fitkit I Checkup KitPatton, Boggs & BlowCDMClass I
K830806Vascular Graft/bifurcated/fep-RingedW. L. Gore & Associates, Inc.DXZClass II
K832451Clear-Rite 3Richard-Allan Medical Ind., Inc.KEMClass I
K832409Lifeline Pacing Leads #471-07 &09Intermedics, Inc.DTBClass III
K832382Carefree * Panty Shields-Reg/deorJohnson & Johnson Professionals, Inc.HHLClass II
K832377Biocuff Infusion Bag PressorBio-Medical Instruments, Ltd.KZDClass I
K832343Dermaland Dural HooksNational Fabtronix, Inc.HAOClass I
K832340Operating Room Tables HydraulicKamiya Tsusan Kaisha, Ltd.BWNClass I
K832334Cryomedics 5000 Cryosurgical ConsoleSpembly Medical, Ltd.GEHClass II
K832325Base Only, Power WheelchairIntl. Medical Equipment Corp.ITIClass II
K832322Base Only, Toronto ChairIntl. Medical Equipment Corp.IQCClass II
K832321Acces. Head Control-Powered CheelchairIntl. Medical Equipment Corp.
K832281Two-Ply Paper Face Face MaskAbco Dealers, Inc.FXXClass II
K832268Rabbit Anti-Human Antithrombin IIIGelco Diagnostics, Inc.JBQClass II
K832255Model F Unipolar Endocardial Lead-Cook Pacemaker Corp.DTBClass III
K832245Unipolar-E Endocardial Tined LeadCook Pacemaker Corp.DTBClass III
K832239Rim-Haemophilus 2Austin Biological LaboratoriesJSTClass I
K832229Bbl Anagel PowderBD Becton Dickinson Vacutainer Systems PreanalyticKZJClass I
K832225Ortho Abnormal Coagulation Level i/iiOrtho Diagnostic Systems, Inc.JPAClass II
K832224Nova Lift ChairNova Health Concepts, Inc.INOClass II
K832198Hc40/hc75 Prepacked ColumsHamilton CoDJYClass I
K832197Prp-1 Reversed Phase ResinHamilton CoDMZClass I
K832188Hall ReciprocatorAmsco Co.GETClass I
K832187Hall OscillatorAmsco Co.GETClass I
K832186Hall Drill/reamerAmsco Co.GETClass I
K832185Ohio Model 922 SpirometerAirco/Ohio Medical ProductsBZGClass II
K832182Lysing ReagentOmega Medical DiagnosticsGGKClass I
K832181Sno Strips Sterile Tearflow Test StripSmith & Nephew, Inc.KYDClass I
K832178Amplatz Heparin Coated CatheterCook, Inc.DQYClass II
K832174Gauze Sponge Non-SterileSudreca Surgical Dressings, Inc.EFQUnclassified