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 3074 of 3528
510(k) clearances, page 3074 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K841707Innofluor PhenobarbitalInnotron DiagnosticsLGQClass II
K841657Patient Tubing Hytrel Siemens-ElemaSiemens Elema ABBZOClass I
K841535Triple Lumen Infusion Catheter/accessGish Biomedical, Inc.
K841529Siemens-Elema Ventilator 900CSiemens Elema ABCBKClass II
K841486Arterial Blood Sampling KitsConcord Laboratories, Inc.CBTClass I
K841470Reese Osteotomy Guide SysOsteotomy Guide Co.HTHClass I
K841279Bear 33Bear Medical Systems, Inc.CBKClass II
K841125Hucksteps StaplesDowns Surgical, Ltd.
K841031Oxyhi Crystalloid Cardioplegia SolutAmerican BentleyDTNClass II
K840992Thermodilution CatheterGould, Inc.KRBClass II
K840824Heparin Coated Thermodilution CathetersGould, Inc.KRBClass II
K840555Waldmann Suntanning Equip-Models'sEurotan Intl.
K840455Emergency Infusion DeviceArrow Intl., Inc.DYBClass II
K840258Tec-3500 DefibrillatorNihon Kohden America IncLDDClass II
K840026Implantable Electrode Unipolar AdaptTelectronics, Inc.DTDClass II
K840025Implantable Electrode Bipolar AdaptTelectronics, Inc.DTDClass II
K834525Angioscan Flo Mad Spectrum AnalyzerUnigon Industries, Inc.JOPClass II
K834501Angioscane Spectrum AnalyzerUnigon Industries, Inc.
K833627Circulator MinibootCirculator Boot Corp.DRNClass II
K832903Esophogral MultiprobeVital Signs, Inc.DRXClass II
K832138Biomer * Pledget Suture ButtressEthicon, IncKGSClass I
K841937Code-a-Well Series 300 PlatePlastic Injectors, Inc.LIBClass I
K841794SunglassesWhole Sale ImportersHQYClass I
K841706Innofluor PhenytoinInnotron DiagnosticsLGRClass II
K841676Disposable Poly GlovesAbco Dealers, Inc.LZAClass I
K841667WunderfilHarry J. Bosworth Co.EBFClass II
K841656Dupont Theophylline Assay KitE.I. Dupont de Nemours & Co., Inc.KLSClass II
K841606Blood Spot Neonatal Tsh RadioimmunoBD Becton Dickinson Vacutainer Systems PreanalyticJLWClass II
K841602Accurate Beta 30 Pregnancy Test KitOrganon LLCLCXClass II
K841601Terumo Sensibead Thyroxine Eia KitTerumo Medical Corp.KLIClass II
K841599Storz Universal Eye ShieldStorz Instrument Co.HOYClass I
K841589C-LiteSuncoast Medical Manufacturers, Inc.KYTClass I
K841588Sun-Lite White SpotSuncoast Medical Manufacturers, Inc.KYTClass I
K841576Technicon Ra-1000 Sys T4-ThyroxineTechnicon Instruments Corp.KLIClass II
K841557Ortho Microwell ReaderOrtho Diagnostic Systems, Inc.JJQClass I
K841555Sigma Procedure 16-UVSigma Chemical Co.CFRClass II
K841543Concentrate Conductivity MeterRenal Systems, Inc.FKQClass II
K841503Kodak Ektachem Dt 60 AnalyzerEastman Kodak CompanyJJEClass I
K841458Number 20 R/l SystemPentron Corp.KLEClass II
K841457Number 21 R/r SystemPentron Corp.KLEClass II
K841423Scotts Tap Water Substitute 7Reagent Laboratory, Inc.JCCClass I
K841330Gastrostomy Feeding TubeMicrovasiveKNTClass II
K841269C-19Pentron Corp.EBFClass II
K841268C-17Pentron Corp.EBFClass II
K841265Tago Diffu-Gen C-Reactive ProteinTago, Inc.DCNClass II
K841089Linear Cloud TonometerLinear Tonometers, Inc.LCHClass I
K840892Electro-PalateCisko SystemsESEClass I
K840868Amresco E4a Reagent SetAmerican Research Products Co.JJEClass I
K840860Centauri CT ScannerTechnicare Corp.JAKClass II
K840859Maks Central Delivery Sys-11-200 EtcErika, Inc.KOCClass II