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 3093 of 3528
510(k) clearances, page 3093 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K840702Secure W/25mm Diam. Sheath & AdhesiveWarne Surgical Products, Ltd.KNXClass II
K840679Serenity Contoured Absorbent ShieldsJohnson & Johnson Consumer Products, Inc.EYQClass I
K840231Disposable Cuvette ArrayConsumable Lab SuppliesJJGClass I
K840225C-Arm Ceiling Crane Ft-2Medicor USA, Ltd.JAAClass II
K840199Emit St Serum Phencyclidine AssaySyva Co.LCMUnclassified
K840164Emit St Urine Methaqualone AssaySyva Co.KXSClass II
K840151Ektachem Clinical Chem. SlidesEastman Kodak CompanyCEDClass I
K840116Deseret Infant Central Venous Cathe-Parke-Davis Co.FOZClass II
K840112Speech TeacherJoseph A. ResnickILPClass I
K840062Bsm 2000 Dialysis MachinebioMerieux, Inc.KOCClass II
K840052Digital Processing SystemPhilips North America LLCIYXClass I
K840004Wee Bag O'mercurySurgi-Quip Inc.ULCCClass II
K834401Ureteral Double Pigtail StentHobbs Medical, Inc.FADClass II
K834351Biliary Indwelling StentHobbs Medical, Inc.FGEClass II
K834192Jakobi Surg. Instruments #3 21/22/24Imm Enterprises, Ltd.KOAClass I
K834191Jakobi Surgical Instruments #3 17/18/19Imm Enterprises, Ltd.KOAClass I
K834136Pbs W/mg+2 & Ca+2Bartels Immunodiagnostic Supplies, Inc.KITClass I
K834126Mrc-5 CellsBartels Immunodiagnostic Supplies, Inc.KIRClass I
K834124Vero CellsBartels Immunodiagnostic Supplies, Inc.KIRClass I
K834123Wi-38 Human Lung CellsBartels Immunodiagnostic Supplies, Inc.KIRClass I
K834120Llc-Mk2-Rhesus Monkey Kidney CellsBartels Immunodiagnostic Supplies, Inc.KIRClass I
K834119Mccoy CellsBartels Immunodiagnostic Supplies, Inc.KIRClass I
K834117Human Fibroblastic Cells-Human NewbornBartels Immunodiagnostic Supplies, Inc.KIRClass I
K833914Cardiac Output Signal AcquistionHewlett-Packard Co.DXGClass II
K833913Hemodynamic Plug-in Module 78551AHewlett-Packard Co.DXGClass II
K832897Model Ttpm Time Temp. Pressure MonitorElectromedics, Inc.DRSClass II
K832095Sevomed Compact Monitor Smk 154-Litton Medical ElectronicsDRTClass II
K832025Servomed Compact Monitor Smk 155-7/101Litton Medical ElectronicsDRTClass II
K831319Patient Monitor #404Analogic Corp.KLKClass II
K8338313-Day Bioindicator Release for SterilShiley, Inc.BTRClass II
K841180Dia-KartMicro Encapsulation Tech.
K841179Hemo-KartMicro Encapsulation Tech.
K841178Alu-KartMicro Encapsulation Tech.
K841003Probes, VariousPremier Dental Products CoKOAClass I
K841159Suction TipsMorwel Corp.
K841155Deodorant Slender Reg. TamponsPlaytex, Inc.HILClass II
K841154Playtex Slender Regular TamponsPlaytex, Inc.HILClass II
K840920Keymed Mobile Endoscopy Patient CouchKeymed, Inc.FPOClass II
K840866Portascoot Power SeatE.F. Brewer Co.INIClass II
K840862Deseret Central Venous CatheterParke-Davis Co.FOZClass II
K840850Anesthesia Ventilator CircuitThe Kendal Co.CAIClass I
K840808Ecu 1218Rehab Technology, Inc.IQAClass II
K840653Bernier Arm SupportT.C. Toll Corp.FNJClass I
K840602Verify Pregnancy Test KitO.T.C. Diagnostics, Inc.LCXClass II
K840595E-Z Open Dust CoversPlasti-Products, Inc.FRGClass II
K840472Sys Macroduct Sweat Collection Sys 3600ELITechGroup IncKTBClass II
K840411Blood & Plasma Admin. Dev-SterileLoversanBRZClass II
K840410Solution Admin. Set SterileLoversanFPAClass II
K840409Infusion Set-SterileLoversanFPAClass II
K840394Stopcocks & Extension TubesAmerican Pharmaseal Div. AhscFMGClass II