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 3176 of 3528
510(k) clearances, page 3176 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K830237Translucent Poly. Cath. Connector andVertex Medical Corp.DQOClass II
K830234Contox Heavymetals ControlKaulson Laboratories, Inc.DIFClass I
K830225The ToothpikFred M. DavisJESClass I
K830217Reagents Corning Chloride Meter forFisher Scientific Company L.L.C.JFSClass II
K830206Tdx N-AcetylprocainamideAbbott MedicalLANClass II
K830204Dac-Cel Diagnatal Hcg Standards Rd49Wellcome DiagnosticsJJXClass I
K830203Dac-Cel Diagnatal Rd 50Wellcome DiagnosticsJHIClass II
K830195No Boil Dual Count Vit-B12 & Folic AcidSiemens Healthcare Diagnostics Inc.CDDClass II
K830191Neuro Diagnostics Model FcrNeurodiagnostics, Inc.GWKClass II
K830179Biocell Spinal Fluid ControlBiocell Laboratories, Inc.JJYClass I
K830175Sterile Cotton Rolls #3, 1 1/2Veratex Corp.EFNClass I
K830171Digital Bedside Scale #5000Acme Medical Scale Co.FRWClass I
K830163Ibm 588 Digital ECG Acquisition/analysisIntl. Business MachinesDSIClass II
K830151External Infusion PumpIntermedics, Inc.FRNClass II
K830116SulcaringsNorth Pacific Dental, Inc.EIFClass I
K830112HydrolNorth Pacific Dental, Inc.EJKClass II
K830107SelfastNorth Pacific Dental, Inc.EMAClass II
K830094Usci Temp. Atrio-Ventricular ElectrodeC.R. Bard IncLDFClass II
K823920Coeurlock Sterile Dispos. AngiographicCoeur Laboratories, Inc.DXTClass II
K823766Blood Gas Incubator #260650Boekel Industries, Inc.JRGClass I
K823739Intra-Aortic Balloon SystemSmec, Inc.DSPClass II
K823559Afp Pulse GeneratorPacesetter SystemsDXYClass III
K823229Suture NeedlesFeuerstein Produktions
K822639Afp System Pulse Generator Model 261/262Pacesetter SystemsDXYClass III
K830174De Vo/44 Oxygen Concentrator #444The Devilbiss Co.CAWClass II
K823748Expanded PTFE Prosthesis Blood AccesC.R. Bard Inc
K830200Microelisa Minireader IIDynatech Corp.LBIClass II
K822859Direct Fa Conjugate for Legionella SppZeus TechnologiesLHLClass II
K822339Kf-101-13 DialyzerExtracorporeal Medical Specialities, Inc.KOCClass II
K822338Kf-101-10 DialyzerExtracorporeal Medical Specialities, Inc.KOCClass II
K822337Kf-101-07 DialyzerExtracorporeal Medical Specialities, Inc.KOCClass II
K830258Centaurset 300 & 300 P.e.dCentaur Sciences, Inc.FPAClass II
K830242Micro 2 Hypodermic NeedlesSmith & Nephew, Mpl DivisionFMIClass II
K830127Quik-Dip Blood StainMercedes Scientific Co., Inc.IAFClass I
K830099Ms-2 Bacterial Identi. SysAbbott MedicalJTOClass I
K830091Lith a Test TmLenal Creative Approaches, Inc.CENClass I
K823927Hipush Handheld MassagerNew Age Corp.ISAClass I
K823923Mf 360B Electrosurgical UnitAspen Laboratories, Inc.GEIClass II
K823701Motility CathetersMui ScientificFFXClass II
K823209Bioself 101Bioself, Inc.LHDUnclassified
K822965Cetus Cmv IhaCetus Corp.LJOClass II
K827346Spiraflow 2001, Multi-Directional Tomographic UnitRayflow Italia S.r.l.
K830082Biggy AgarbioMerieux, Inc.JSIClass I
K830080Bile Esculin Azide AgarbioMerieux, Inc.JSJClass I
K830065Salmonella-Shigella AgarbioMerieux, Inc.JSIClass I
K830232Decanter Models-VariousSteri-Sytems, Corp.KPEClass II
K830230Programmable VentilatorBio-Med Devices, Inc.CBKClass II
K830226Surgitek Percutaneous Nephrostomy CathMedical Engineering Corp.LJEUnclassified
K830166Molnlycke Ete Sterile Non-Adherent DressLada Intl., Inc.NABClass I
K830156Hcg Screening TestTago, Inc.JHJClass II