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 3228 of 3528
510(k) clearances, page 3228 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K821023Thoracic Drainage SystemHowmedica Corp.GCXClass II
K820909Gore-Tex Peritoneal CatheterrW. L. Gore & Associates, Inc.FJSClass II
K820813Lesser Metatarsal Phalang. Joint ProsthSutter Biomedical, Inc.KWHClass II
K820739Keymed Key Vac Suction PumpKeymed, Inc.BTAClass II
K820575J.e.t. Dialysis SystemComputer Dialysis Systems, Inc.FKJClass II
K827450Simplamatic IIISpectrum X-Ray Corp.
K827448Bsinus DiaphanographSinus Medical, Inc.
K827442Ml-810 Carbon Dioxide Laser SystemMerrimack Laboratories
K827379X-Ray CassetteSynchroplan Corp.
K827378Diagnostic X-Ray Hv GeneratorTechnicare Corp.
K821304Centralyte Bicarbonate ConcentrateErika, Inc.KPOClass II
K821235Heparin Coated Thermodilution CatheterGould, Inc.DYGClass II
K821173Eventmaster 3 Holter Event ScannerInstruments for Cardiac ResearchDSFClass I
K821158Fed Ringed-Tex Vascular GraftW. L. Gore & Associates, Inc.DSYClass II
K821149Submission Coronary CannulaDlp, Inc.DWFClass II
K821137Meditrace Pellet ElectrodeGraphic Controls Corp.DRXClass II
K821129Airlife Nebulizer HeaterAirlife, Inc.CAFClass II
K821099Heparin Coated Thermodilution CatheterKma, Inc.DYGClass II
K821057Flow Directed Thermal-Dilution InfusionOximetrix, Inc.DYGClass II
K821056Flow Directed Thermal-Dilution CatheterOximetrix, Inc.
K820912Pms-2 Pressure Monitor SeparatorDelta Medical IndustriesDXSClass II
K820881Memoport CLitton Medical ElectronicsDSIClass II
K820667Pressure-StatAlvin H. Sacks, Ph.D.DXNClass II
K820658Lixiscope - or LixiLixi, Inc.OXOClass II
K813268Sc-2500F Cardiotomy ReserviorScimed Life Systems, Inc.DTNClass II
K821357Modified Neuro Surgery Nibbling ForcepsDowns Surgical, Ltd.HAOClass I
K821307AnesthecacheMed-Life, Inc.BRYClass I
K821257SelofixSelomas, Inc.KGXClass I
K821244Disposable Temperature ProbeShiley, Inc.FLLClass II
K821233Disposable Plastic Syringe W/needleTaiyang Corp.FMFClass II
K821228Deknatel Skin Staple ExtractorHowmedica Corp.GAGClass II
K821218Campy-S AgarIsle Media and Sterile Products, Inc.JSJClass I
K821183Target Isocheck Control SerumSmithkline Diagnostics, Inc.JJTClass I
K821179Visidex Reagent StripsMiles Laboratories, Inc.CGAClass II
K821175Gastrin Radioimmunoassay Kit (125-I)BD Becton Dickinson Vacutainer Systems PreanalyticCGCClass I
K821174Tsh-Squibb Radioimmunoassay KitSquibb & Sons, Inc.JLWClass II
K821167Uricase (u.v.) Uric AcidSyn-Kit, Inc.CDOClass I
K821162Adhesive RemoverThe Healthcare Group Laboratories, Inc.KOXClass I
K821145I-Dhea-Sulfate Ria Kit 125Nuclear Medical Systems, Inc.JKCClass I
K821096A-LinerMartell Medical Products, Inc.FMFClass II
K821091Accuchek Bg.Biodynamics Corp.CGAClass II
K821087Anesthesia Breathing CircuitLife Design Systems, Inc.CAIClass I
K821024Disp. Skin Stapler Removalble SkinstapleHowmedica Corp.GDTClass I
K820960Maxi & Mini ShieldsDafoe & Dafoe, Inc.HHDClass I
K820905Beckman Mmc II Metabolic Meas. CartBeckman Instruments, Inc.BZLClass II
K820899Mecron Voorhoeve Titanium SheathSerrano Intl.
K8208888700 Clinical Chem. AnalyzerBoehringer Mannheim Corp.JJEClass I
K820759Vein-ShieldPan-Tech Research, Inc.KMKClass I
K820619Mecron(r) Acetabular Nets TmSerrano Intl.FTMClass II
K820520Vd AlertIntl. Research Distributors, Inc.LIOClass I