510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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
46,018 of the 176,415 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
20262,618
176,415 records, page 2997 of 3529
510(k) clearances, page 2997 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K844249K-SolCilco, Inc.LYXUnclassified
K841104Enternal Feeding Pump Battery Oper.Fresenius USA, Inc.
K851518Mueller Hinton Sensitivity PlateCulture Kits, Inc.JTZClass II
K851494Two-Step Acid Fast Bacteria StainAccra Laboratories, Inc.JTSClass I
K851493Kinyoun Acid Fast Stain KitAccra Laboratories, Inc.JTSClass I
K851482TourniquetPolymer Technology Corp.GAXClass I
K851481Spottest Iodine Solution Dobell & O'connorDifco Laboratories, Inc.LEDClass I
K851454A-Company Stainless Steel Orthodontic BracketsA Company, Inc.ECQClass I
K851453Hospal Fistula NeedleHospal Medical Corp.FIEClass II
K851386Unitek Disposable Impression SyringeUnitek Corp.EIDClass I
K851350Ion 2 Reagent KiHi Chem, Inc.CEMClass II
K851330Prolactin System by RiaAmerican Bioclinical, Inc.CFTClass I
K851267Gemeni Ast-Lts ReagentsElectro-Nucleonics Laboratories, Inc.CITClass II
K851234A-Just Turbidity MeterAbbott MedicalJQXClass I
K851224West Bend Electric ThermometerThe West Bend Co.FLLClass II
K851202Gilford Tri-Level Assayed Immunology ControlGilfordDAKClass II
K851183Pepsodent Denture Cleanser Pdp FormulaLever Brothers Company, Inc.EFTClass I
K851182Pepsodent Denture Cleanser-Westone FormulaLever Brothers Company, Inc.EFTClass I
K851173Abco Tray Care KitsAbco Dealers, Inc.
K851148Tsh Irma(125i) Btsi 1(Thyroid Stimula-HormoneEuro-Diagnostics BVJLWClass II
K851058Dosi FlowLeventon, S.A.LDRClass II
K851043Sugar-Chex IIStreck Laboratories, Inc.JJXClass I
K851042Sugar-ChexStreck Laboratories, Inc.JJXClass I
K851038Arcee Dental PostArcee Dental Products Co.ELRClass I
K850477Noninvasive Electronic Digital Bp Monitor Ebm-2050Unisonic Products Corp.DXNClass II
K850476Noninvasive Electronic Digital Bp Monitor Ebm-1050Unisonic Products Corp.DXNClass II
K850385Intracardiac Sump 12010Dlp, Inc.DWFClass II
K850029Utah Pressure Transducer Calibrator Tru-CalUtah Medical Products, IncBXXClass I
K845043Jms Needles & Jms SyringesJMS Co., Ltd.FMIClass II
K844803Polyester Cardiotomy Reservoir, Filtered & UnfilteElectromedics, Inc.DTPClass II
K844735Pth-RiaSyncor Intl. Corp.CEWClass II
K844679Dsl Pap Ria -Dsl#3100Diagnostic Systems Laboratories, Inc.JFHClass II
K8515314013 Non Conductive Anesth. Circuit W/breath-BagSigma Medical, Inc.CAIClass I
K8515304003 Non Conductive Anesthesia Circuit W/breat\gasSigma Medical, Inc.CAIClass I
K8515294010 Non Conductive Ventilator Circuit W/bacterialSigma Medical, Inc.CAIClass I
K851380Disscap 110 DialyzerHospal Medical Corp.FJIClass II
K851321Atac 2000 Chemistry AnalyzerTurpen Laboratory Systems, Inc.JQPClass I
K851239Active Dhea-Sulfate Dsl3500Diagnostic Systems Laboratories, Inc.JKCClass I
K851206Shoulder-HolderBiodynamic Technologies, Inc.
K851180Irrigation TrayPace Pharmaceutical Services, Inc.KODClass II
K851179Catheter Care TrayPace Pharmaceutical Services, Inc.KODClass II
K851170Dissecting Tweezer #283-72Pcs. Ss 410The Huxley Instrument Corp.GENClass I
K851157Surgimed - Surgical BladesSurgimed Corp.GESClass I
K851156Pharmacia Ige Ria ModifiedPharmacia, Inc.DGCClass II
K851122Pi-Pneumo Intestinal Stapling CartridgeSurgeons Choice, Inc.GDWClass II
K851121Pi-Pheumo Intestinal Instrument SetSurgeons Choice, Inc.GAGClass II
K851116Judd-Aillis Tissue Forceps 1820-118 Pcs. Ss 410/42The Huxley Instrument Corp.GENClass I
K851115Finocchieto Rib Retractor 1711-72 Pcs. Ss 303, 420The Huxley Instrument Corp.GADClass I
K851114Magill Forceps 1711-46 Pcs. Ss 410 or 420The Huxley Instrument Corp.GENClass I
K851109Volkman Retractor 704-8520 Pcs. Blunt-4 Prong Ss42The Huxley Instrument Corp.