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 3071 of 3528
510(k) clearances, page 3071 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K841630Enteral Nutrition PumpSuperior Plastic Products Corp.FRNClass II
K841612Neuropack II 5100Nihon Kohden America IncGWLClass II
K841497Neuropack 8 Mee 4108Nihon Kohden America IncGWKClass II
K841370Kma-1300FMedimex, Inc.BSZClass II
K841215Glattelast Compression StockingsBaurs Krey Assoc., Inc.DWLClass II
K841174Rubella Antibody FluoroimmunoassayIntl. Diagnostic TechnologyGOLClass II
K841157Halothane Vaporizer 950, EnfluraneSiemens Elema ABCADClass II
K840957Antimicrobial Incise DrapeAmerican Convertors Div., American PharmasealKKXClass II
K840799V.d.t.-Gonorrhea Test KitM.G. Laboratories, Inc.LIOClass I
K840744Transporter Viral Transport MediumBartels Immunodiagnostic Supplies, Inc.KITClass I
K840722EnteroscopeTrimedyne, Inc.FDAClass II
K840692Contact Lens Case for Soft LensesOptimum Manufacturers, Inc.LRXClass II
K840687Kidney Transplant CatheterWarne Surgical Products, Ltd.KDNClass II
K840326Gas Supply Manifold Siemens-Elema AbSiemens Elema ABCAMClass I
K834535Nitrous Oxide RecyclerG & L Unltd.BSFClass I
K842222Dupont Aca Liquid Bilirubin CalibratorE.I. Dupont de Nemours & Co., Inc.
K841894Vmt Hand Held NebulizerVortran Medical Technology 1, IncCCQClass I
K841883Surgeon's Blades Sterile BladeAn-Med Intl.GESClass I
K841882Three Way Infusion SetMed Fusion Systems, Inc.FPAClass II
K841851Hpd Humidifier WickHpd Medical, Inc.BTTClass II
K841818Impulse VentilatorHealthdyne, Inc.CBKClass II
K841732Liebel-Flarsheim Afc 1000 X-Ray FilmSybron Corp.IZPClass II
K841728Lci Medical Inc Air/palLehigh Consolidated IndustriesFRZClass II
K841669Flash GuardSparco, Inc.
K841649Maximax - 4Cgr Medical Corp.IZPClass II
K841616Timex Healthcheck Digital Bp MonitorTimex Medical Products Corp.DXNClass II
K841615Elecath Heparin-Coated CathetersElectro-Catheter Corp.DQOClass II
K841593Axiom Thoracic CathetersAxiom Medical, Inc.
K841525Oreia II B-Hcg Pregnancy Test KitOrganon LLCJHIClass II
K841515Scanlan Vascu-Statt IIScanlan Intl., Inc.HRGClass I
K841514Scanlan Vascu-Statt II ApproximatorScanlan Intl., Inc.HRQClass I
K841468PMA Angiography TrayProfessional Medical ServicesDWSClass I
K841440Nd62t Thyroid Uptake SystemNuclear Data, Inc.IZDClass I
K841301Gardner Type Bone Marrow NeedlePopper & Sons, Inc.GAAClass I
K841300Antrum Needle-Wolf TypePopper & Sons, Inc.
K841165Electro Surgery SystemMicro-Aire Surgical Instruments, Inc.GEYClass I
K840648Temprobe MonitorVital Signs, Inc.FLLClass II
K840621Fluoroscopic Image IntensifierPhoenix Radiology, Ltd.JAAClass II
K834211Leap FrogPhilips North America LLCDSIClass II
K833779Yttro FilterYttro Corp.IZWClass II
K831531Surgical Isolation Barrier SystemLone Star Medical Products
K841306Heparin Lock Flush Solution Usp Kit,100Solo Pak LaboratoriesFMIClass II
K841305Heparin Lock Flush Solution Usp KitSolo Pak LaboratoriesFMIClass II
K841249Suction CannulasCustom Surgical Products, Inc.GEAClass I
K841166Heparin Lock Flush Procedure PackSolo Pak LaboratoriesFMIClass II
K842182Titertek-Enterobac Rapid AutomatedFlow Laboratories, Inc.
K842036Biphasic Blood Culture BottleGibco Laboratories Life Technologies, Inc.JSGClass I
K841951Microsurgical KnifeEthicon, IncHNNClass I
K841815Optimate Iga TestMiles Laboratories, Inc.CZNClass II
K841768Woodlyn Lightweight Trial FrameWoodlyn, Inc.HPAClass I