510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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 3155 of 3528
510(k) clearances, page 3155 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K831297Prototro/proteolytic Enzyme ControlAmerican DadeJBQClass II
K831286Ultipore Prebypass Plus FilterPall Biomedical Products Co.KRJClass II
K831280Ney-Oro 60Deringer-Ney, Inc.EJTClass II
K831270Dispos. Medication NebulizerHospitak, Inc.CAFClass II
K831269Vinylac Press-Pack Denture ResinAstron Dental CorporationEBIClass II
K831264Bhcg Ria KitMicromedic SystemsJHIClass II
K831183Gauze Sponge Sterile SpongeDen Med, Inc.EFQUnclassified
K831182Gauze Sponge-Non-Sterile SpongeDen Med, Inc.EFQUnclassified
K831172UltrakitStaar Surgical AGHQCClass II
K831140Dade Hematology CalibratorAmerican DadeKRXClass II
K831136Double Bow Tooth SeparatorAlmore Intl., Inc.JEPClass I
K831133Amebiasis Bio-Enzabead Screen KitBionetic Laboratory ProductsKHWClass II
K831131Case Wright-Giemsa Stain PakCase InstrumentsHYFClass I
K831094Para LasarStreck Laboratories, Inc.JPKClass II
K831090Hematoxylin Gill Formulation Ix#56016Accra Laboratories, Inc.HYJClass I
K831085Synevac Vacuum Source UnitSynemed, Inc.BTAClass II
K831072Jurgan Pin BallJurgan Development & Mfg., Ltd.LYTClass II
K831071Universal Instru. Set for NeurovascularProthia USA, Inc.GZXClass I
K831065Sectioning Aid KitTechnicon Instruments Corp.KEWClass I
K831061Pva Fixative/formalinAmerican Micro ScanLDZClass I
K831060Trichrome StainAmerican Micro ScanJTSClass I
K831058Saf FixativeAmerican Micro ScanLDWClass I
K831055Hemoglobin Electrophoresis Meth on the-Olympus Corp.JBOClass II
K831013Diagnostics Po 2 ElectrolyteFisher Scientific Company L.L.C.CHLClass II
K831012Diagnostics Pco2 Electrolyte W/carbonFisher Scientific Company L.L.C.CHLClass II
K830908Bicarbonate/variable Sodium Kit-Dm-367Extracorporeal Medical Specialities, Inc.FKQClass II
K830877Ap-CheckGeneral DevicesGYAClass I
K830858Bio-Probe System-Blood Flow ProbeBio Medicus, Inc.DPTClass II
K830853Lavatory Seat HeightenerLic-OrthionILSClass I
K830820Legionella Dfa Kit IBionetic Laboratory ProductsLHLClass II
K830812Alphamedix I/a Hand-Piece, 500-001Alphamedix, Inc.HQCClass II
K830713Ls-1 Portable Blood Pressure ComputerVita-Stat Medical Services, Inc.DXNClass II
K830673Crafon Arthroscopy LinesGambro, Inc.HRXClass II
K830665Hepcol System B-10 & B-10-PHemotec, Inc.JOXClass II
K830587Vital Signs Monitor 2Physio Control, Inc.DRTClass II
K830475Brain Module Rj-Z10Instrumentation Industries, IncorporatedCAIClass I
K830472LiposolQuest Medical, IncJKAClass II
K830268Floret Cylindrical/bronchoscopic/laminRitmed, Inc.EFQUnclassified
K830267Floret Special Gauze SpongesRitmed, Inc.EFQUnclassified
K830266Floret Kittner or K DissectorRitmed, Inc.EFQUnclassified
K830261Floret Strung Gauze SpongesRitmed, Inc.EFQUnclassified
K830123Disp. Yankaver Surg. Suction InstrumentNarco ScientificGCYClass I
K822413Weyland Extension VibratorMedical Management Service, Inc.JFBClass II
K837329Sonacolor Cd, Model 6300 Cardiac Doppler UltrasoundCarolina Medical Electronics
K831551Compressogrip Tubular Elastic BandageFred Sammons, Inc.FQMClass I
K831482Clirans Taf 120 Hollow Fiber Dialyz. &Terumo Medical Corp.KOCClass II
K831440Single Needle Subclavian Vein Mwi250/260Med-West, Inc.FIQClass II
K831412Crm-100 Color Video CameraUmi, Inc.FETClass II
K831401Single Needle Subclavian Vein AccessMed-West, Inc.FIQClass II
K831376Cds 2001 Artificial KidneyElmar Medical Systems, Ltd.KOCClass II