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 2924 of 3529
510(k) clearances, page 2924 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K854748Travelpak Model Dc-202Travomed, Inc.CAWClass II
K854576Modified Cordis Ptca Guiding CathetersCordis US Corp.DQOClass II
K854572Coatest PlasminogenKabivitrum, Inc.DDXClass I
K854500Heater Probe-Access for Medpacific Ld5000 Laser -Medpacific Corp.DPWClass II
K854128Oscor Medical Unipolar Permanent Pacing Lead-ConneOscor Medical Corp.DTBClass III
K853926Neocare Model 800 Infant Radiant WarmerDraeger, Inc.FMTClass II
K852829Cardisuny 501 aAtrixDPSClass II
K852421Sentry II Nonindwelling Blood Pressure MonitorNbs Medical, Inc.DXNClass II
K851241Greco-Harvey Surfactant Bonded Catheter for CardioCook, Inc.DQYClass II
K860463Single and Dual Tourniquet CuffAspen Laboratories, Inc.KCYClass I
K854806Rapid Solution Admin Set W/integral Heat ExchangerGrant Medical CenterFPAClass II
K854711Fibrelight Illuminating Oral RetractorsDowns Surgical, Ltd.EIGClass I
K854058Pk-Ac Powered Patient Manupulating DeviceMannesmann Demag Corp.FNGClass II
K860489Eurotan by AykEurotan Intl.FTCClass II
K860466Model 329D, Seriers R Biopolar Cardiac Pul. Gen.Cook Pacemaker Corp.DXYClass III
K860420Sickle Cell Reagent SetSterling Diagnostics, Inc.GHMClass II
K860416Biotis Regan-LoweOtisville Biotech, Inc.JSJClass I
K860415Biotis Simmon Citrate AgarOtisville Biotech, Inc.JSEClass I
K860414Biotis Ornithine Indole Motility MediaOtisville Biotech, Inc.JSEClass I
K860413Biotis TsiOtisville Biotech, Inc.JSEClass I
K860412Biotis Sim MediumOtisville Biotech, Inc.JSEClass I
K860411Biotis Bhi AgarOtisville Biotech, Inc.JSGClass I
K860410Biotis Cooked MeatOtisville Biotech, Inc.KZIClass I
K860409Biotis Columbia Sheep Blood AgarOtisville Biotech, Inc.JSGClass I
K860408Biotis Nutrient AgarOtisville Biotech, Inc.JSGClass I
K860407Biotis Anaerobic CnaOtisville Biotech, Inc.JSJClass I
K860406Biotis Middlebrook 7H9 BrothOtisville Biotech, Inc.JSJClass I
K860405Biotis Tsb with 6.5% NaclOtisville Biotech, Inc.JSJClass I
K860404Biotis Middlebrook 7H10 Agar SlantOtisville Biotech, Inc.JSJClass I
K860403Biotis Tsa with 5% Rabbit BloodOtisville Biotech, Inc.JSGClass I
K860402Biotis Bismuth Sulfite AgarOtisville Biotech, Inc.JSIClass I
K860401Biotis Tryptic Soy Agar SlantsOtisville Biotech, Inc.JSGClass I
K860399Biotis Todd Hewitt BrothOtisville Biotech, Inc.JSGClass I
K860398Biotis Potato Dextrose AgarOtisville Biotech, Inc.JSJClass I
K860397Biotis TsaOtisville Biotech, Inc.JSGClass I
K860396Biotis Nutrient GelatinOtisville Biotech, Inc.JTOClass I
K860395Biotis Haemphillus Isolation AgarOtisville Biotech, Inc.JSJClass I
K860394Biotis Cetrimide AgarOtisville Biotech, Inc.JSJClass I
K860391Biotis Middlebrook 7H11 Broth & Agar SlantOtisville Biotech, Inc.JSJClass I
K860390Biotis Sabhi with Chloramphenical and GentamycinOtisville Biotech, Inc.JSJClass I
K860388Biotis Kf Streptococcus AgarOtisville Biotech, Inc.JSIClass I
K860386Biotis Sf BrothOtisville Biotech, Inc.JSIClass I
K860385Biotis Mac-MugOtisville Biotech, Inc.JSIClass I
K860384Biotis Modified Thayer MartinOtisville Biotech, Inc.JTYClass II
K860383Biotis Clostridium Difficile AgarOtisville Biotech, Inc.JSJClass I
K860202Model 327D, Series R Unipolar Cardiac Pulse Gener.Cook Pacemaker Corp.DXYClass III
K855140Angiomed Renal Dilation SetAngiomed U.S., Inc.KODClass II
K855119S.l.t. Contact LaserSurgical Laser Technologies, Inc.LNKClass II
K855117Sysmex E-2500 Automated Hematology SystemToa Medical Electronics USA, Inc.GKZClass II
K855116Sysmex E-5000 Fully Automated Hematology SystemToa Medical Electronics USA, Inc.GKZClass II