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 3211 of 3528
510(k) clearances, page 3211 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K821627The Artificial Urinary SphincterAmerican Medical Systems, Inc.FAGClass III
K821393System One Oxygen ConcentratorMarathonCAWClass II
K821026Bi-Level Assayed Tumor Marker & AntinOrtho Diagnostic Systems, Inc.JJYClass I
K827287Model 8100 Sector ImagerOte Biomedica
K827286Model 8000 Sector Imager SystemOte Biomedica
K822246Noninvasive Temporary PacemakerRoss Research, Inc.DROClass II
K822147Medtronic Enertrax Model 7100Medtronic, Inc.DXYClass III
K822020Ckg 8000Cardio Kinetics, Inc.DSBClass II
K822014Nagashima Su-a Ceiling Mount Unit forKelleher Corp.EPTClass I
K821947Fastpass Implantable Endocard. PacingPacesetter SystemsDTBClass III
K821889Porous Surfaced Platinum IridiumCordis US Corp.DTBClass III
K821673Heart*aid, Als, Model 95Cardiac Resucitator Corp.DROClass II
K821538Capiox Cr-Cardiotomy ReservoirTerumo Medical Corp.DTPClass II
K821321Snyder Debribement System Ldp-1Snyder Laboratories, Inc.BTAClass II
K821316Kontron Litwak-Koffsky Obturated CannuKontron Instruments, Inc.DWFClass II
K821246MelolinSmith & Nephew, Inc.NABClass I
K821169Mpi Mon-It II, Smart Safety SystemMedical Plastics, Inc.GEIClass II
K821152Heart Aid #90Cardiac Resucitator Corp.DROClass II
K820989Medtronic #6993Medtronic, Inc.DTBClass III
K820609Heart *Aid, #80Cardiac Resucitator Corp.DROClass II
K820507Pace* Aid Model 50Cardiac Resucitator Corp.DROClass II
K8222072Xc MicroscopeAmarel Precision Instruments, Inc.IBJClass I
K822154Urea Nitrogen (Enzymatic) DeterminationThe Dow Chemical Co.CDNClass II
K822146Corning 101 PrinterCorning Medical & ScientificJQPClass I
K822140Immuchem Covalent-CoatImmuchem Corp.JKCClass I
K822132Dade Chill TrayAmerican DadeJRRClass I
K822129Volu-Sol Bovins FixativeVolu Sol Medical IndustriesIGNClass I
K822128Volu-Sol Single Differential StainVolu Sol Medical IndustriesICNClass I
K822127Volu-Sol Zenkers FixativeVolu Sol Medical IndustriesIFHClass I
K822126Volu-Sol Carnoy FluidVolu Sol Medical IndustriesIGMClass I
K822123Isopropanol Hemoglobin Stability TestHelena Laboratories, Corp.GKAClass II
K822121Acro PackGelman Sciences, Inc.JRLClass I
K821995Solution Administration Set (W/o Needle)Bertex Laboratories, Inc.FPAClass II
K821659Respiracult-Strep Deep Bed Culture PadOrion Diagnostica, Inc.JSHClass I
K821649Monaghan's Pressure AlarmMonaghan Medical Corp.CAPClass II
K821362Improved Gono GenNew Horizons Diagnostics Co.LICClass II
K822141Phadebas Rast TestPharmacia, Inc.DHBClass II
K822134Shiely Duel Lumen Subclavian CannulaShiley, Inc.LFJClass II
K822133Ige/the Ophylline Control Serum I,ii,iiiKallestad Laboratories, Inc.JJYClass I
K822131Dermatophyte Test MediumGranite Diagnostics, Inc.JSDClass I
K822119Accessory Media for Flow Titertek MicFlow Laboratories, Inc.JTZClass II
K822038Volu-Sol Orange G-6(Gills-ModVolu Sol Medical IndustriesHZHClass I
K822037Volu-Sol Tap Water SubstituteVolu Sol Medical IndustriesPPMClass I
K822036Volu-Sol DecalciferVolu Sol Medical IndustriesKDXClass I
K822035Volu-Sol Gills EaVolu Sol Medical IndustriesHZJClass I
K822026Immuno Diagnostics AssayHelena Laboratories, Corp.CZPClass II
K822018Jackson Bite BlocksKelleher Corp.JXLClass II
K821994Disposable Linear Stapler-(Lsr)Ethicon, IncGDWClass II
K821967Chlamydelisa Test KitM.A. BioproductsLJCClass I
K821932Mentor Potential Acuity MeterMentor O & O, Inc.HOXClass I