510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK 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
46,132 of the 176,529 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
20262,732
176,529 records, page 2484 of 3531
510(k) clearances, page 2484 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K910031Park City Shoulder PositionerMizuho Orthopedic Systems IncFWZClass I
K910009Hypoallergenic Latex Examination GlovesStraitscomLYYClass I
K905574Slim Line Retention Tip W/ Silicone Rubber CuffE-Z-EM, IncFGDClass II
K905259Vista Hpq SystemPhilips North America LLCLNHClass II
K905110Liatest(r) at III Test KitAmerican Bioproducts Co.JBQClass II
K904907Endopath Disposable Surgical Trocar ReducerEthicon, IncHETClass II
K904587Densicomp 250L. Keroack Co.KPWClass II
K903714E. Coli 0157 Latex TestPro-Lab, Inc.GNAClass I
K896100Eub-565 Diagnostic Ultrasound DeviceHitachi Medical Corp. of AmericaIYOClass II
K910150Romflex Rehab Equip Extremities UnitDyna Flex, Intl.BXBClass I
K910072Sure Grip, Hand Controls Model Sg-1Howell Ventures, Ltd.IPQ
K905762Gen-Probe Luminometer-Leader 450Hologic, Inc.JJQClass I
K905656Flagen Triiodothyronine (T3) AssayCyberfluor, Inc.CDPClass II
K905568Topical Cooling Pad, Model 7000Daily Medical Products, Inc.DTRClass II
K905376Storz S6000 Light SourceStorz Instrument Co.FCWClass II
K905265620 Fluoroscopic Table, Tilt or Power Medical TabTri W-G, Inc.IXRClass II
K905261Imx Free TriiodothyronineAbbott MedicalCDPClass II
K905008Flexible Intracardiac Suction DeviceGish Biomedical, Inc.DTSClass II
K904989Clp Low Level Hdl Cholesterol-Lipid Control-IICreative Laboratory Products, Inc.JJYClass I
K904722Fluoroscopic Table, Tilt or Power Tilting Med. TabTri W-G, Inc.
K904161Jmb Trading Company SunglassesJmb Trading Co.HQYClass I
K903975Serozyme Cortisol Test KitSerono-Baker Diagnostics, Inc.CGRClass II
K903842St-E1 OvertubeOlympus Corp.FEDClass II
K903715Condom SealMark Sullivan, M.D., P.C.EXJClass I
K903529Bml SeriesOlympus Corp.LQCClass II
K903104Capnomac Ultima (Tm) Anesthesia MonitorDatex Division Instrumentarium Corp.CBQClass II
K905463General Medical Procedure Kit/skin PreparationAngiosystems, Inc.FOZClass II
K905207Micro-Aire Soft-Ice, Cold Therapy CompressMicro Surgical Instruments Corp.IMEClass I
K904845Storz Draeger Rotor KeratomeStorz Instrument Co.HNOClass I
K904802Video OtoscopeJEDMED Instrument CompanyERAClass I
K903808Amsis Rds, Radiographic Discography KitAdvanced Med/Surg, Inc.IZGClass II
K910151Romflex Rehab Equip Cervical Flexor UnitDyna Flex, Intl.BXBClass I
K910149Romflex Rehab Equip Lateral Flexion UnitDyna Flex, Intl.BXBClass I
K910026Ati Medical Comfort Plus Cpm PadAti Medical, Inc.BXBClass I
K905735Genny Denny IV ShieldTadco, Inc.KMKClass I
K905685Zenith Cox Flexion Chiropractic TableWilliams Manufacturing Co.INQClass I
K905678AladermAladan Corp.LYYClass I
K905637Illumina Model 780 CO2 Laser SystemHeraeus Lasersonics, Inc.GEXClass II
K905501Elite 5000Fischer Imaging Corp.IXRClass II
K905229Laparoscopic Cholangiography Catheterization SetsArrow Intl., Inc.FGEClass II
K905055Pm GlovePM Gloves, Inc.LYZClass I
K905042Comfort Sleeved All Silicone Foley CatheterRochester Medical Corp.EZLClass II
K905031Patient Examination GlovesPhoenix Medical Technology, Inc.LYZClass I
K904828Optec 2300 Afvt, Armed Forces Vision TesterStereo Optical Company LLCHKOClass I
K904779Button Replacement Gastrostomy DeviceC.R. Bard IncKGCClass II
K904589Kodak Surecell(tm) Strep a Control Fluid SetEastman Kodak CompanyGTYClass I
K904255Focus T41,t41f,t43, T43f,t44fElamedicalDTBClass III
K904247Free Protein S Reagent Cat. No. 5363Helena Laboratories, Corp.GGPClass II
K904222Vista Graph Polysomnography AmplifierTelediagnostic Systems, Inc.GWLClass II
K903917Compact Monitor Smk 210,211,230,231,240Ppg Hellige B.V.DSPClass II