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 3290 of 3528
510(k) clearances, page 3290 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K811375Bi-Ra Slide TestBiologics Intl., Inc.DHRClass II
K811374Bi-Crp Latex TestBiologics Intl., Inc.DCNClass II
K811294Gambro Peritoneal Dialysis Fluid LinesGambro, Inc.KDJClass II
K811284Gc Ttansport SystemBiolog, Inc.JTWClass I
K811283Jembec Transport SystemBiolog, Inc.JTWClass I
K811282Selective Gc Culture MediumBiolog, Inc.JTYClass II
K811281Gc Culture MediumBiolog, Inc.JTYClass II
K811247Catheter Maintenance KitClinipad Corp.FRGClass II
K811225Human Blood in Alsever'sDutchland Laboratories, Inc.JSKClass I
K811215Kermath Radiographic Head StandKermath Mfg. Corp.KPRClass II
K811141Sechrist Infant Ventrilator Model IV-100Sechrist Industries IncCBKClass II
K811122Del Mar Avionics Models 9400 & 9401Del Mar AvionicsDSIClass II
K811107IV SetsCritikon Company, LLCFPAClass II
K811079SyphgmologCardiodyne General, Inc.DSKClass II
K811009Prefilled Pulsator SyringeConcord Laboratories, Inc.FMFClass II
K810975MinitoneBloomex International, Inc.IPFClass II
K810841MedaidC.V.I., Inc.GZJClass II
K810795InstafilInstafil, Inc.KPEClass II
K810765Hy-Bond Zinc Phosphate CementShofu Dental Corp.EMAClass II
K810764Hy-Bond Polycarboxylate CementShofu Dental Corp.EMAClass II
K810634Firm-a-TronBiotron, Ltd.IPFClass II
K811110Models: 52-01-0, 52-01-1YFPAClass II
K810130Optocryl Contact Lens BlanksOptacryl, Inc.HPXUnclassified
K811504Wako Uric Acid B TestFUJIFILM Healthcare Americas CorporationKNKClass I
K811480Thermodilution KitAmerican Pharmaseal Div. AhscKRBClass II
K811462Emit-Cad Quindine ControlSyva Co.LASClass I
K811461Emit-and Methotrexate ControlSyva Co.LAZClass I
K811460Emit-Cad Quinidine AssaySyva Co.LBZClass II
K811459Emit-and Methotrexate AssaySyva Co.LAOUnclassified
K811454Vance Prostatic Aspiration SetVance Products, Inc.KNWClass II
K811451Radial Head ProsthesisCintor Orthopaedic Div.JDBClass II
K811438Acratrac RAvratronics Corp.INWClass I
K811431Technicon Star SystemTechnicon Instruments Corp.JLWClass II
K811430Anesthesiology DeviceVital Air Oxygen Co.CANClass I
K811423Ventre/sepVentrex Laboratories, Inc.CFPClass I
K811404TravelaireB & F Medical Products, Inc.CCQClass I
K811399Edslab Closed Injectate Delivery SystemAmerican Edwards LaboratoriesKRBClass II
K811393Downs Cap Flow GeneratorVital Signs, Inc.BZRClass II
K811380Estriol KitCambridge Nuclear Corp.CGIClass I
K811379Shiley Arterial FilterShiley, Inc.DTMClass II
K811368Cardioplegia Cooling & Admin. SetsBentley Laboratories, Inc.KRIClass I
K811312Myo-Metric IIMycron Medical, Inc.LBBClass II
K811300Economy Open End Drainage BagEconomy PlusEXBClass I
K811239Sur-Fit Disposable Convex InsertE. R. Squibb & Sons, Inc.EXBClass I
K811228Sorenson Catalog #Ifl-120SSorensen ResearchCACClass II
K811197Superix 120Tecnomed, Inc.IZFClass II
K811196Allmec 90/15Tecnomed, Inc.KXJClass II
K811195ArgostatTecnomed, Inc.IYBClass I
K811149Pandoros 1200ASiemens Corp.IZIClass II
K811142Belmont Podiatry Model 065 X-RayBelmont Equipment Corp.KPRClass II