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 2824 of 3529
510(k) clearances, page 2824 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K870651Biggy AgarHardy MediaJSHClass I
K870650Neomycin Anaerobic Blood AgarHardy MediaJSJClass I
K870649Mrsa Screen Agar (Mueller Hinton W/nacl & Oxacil.)Hardy MediaJTZClass II
K870648Staphylococcus 110 AgarHardy MediaJSIClass I
K870647Columbia Cna AgarHardy MediaJSJClass I
K870646Middlebrook 7H10 AgarHardy MediaKZIClass I
K870645Middlebrook 7H11 Selective AgarHardy MediaJSJClass I
K870644Brilliant Green AgarHardy MediaJSIClass I
K870643Potato Dextrose AgarHardy MediaJSIClass I
K870642Cooked Meat Medium with IronHardy MediaKZIClass I
K870641Tryptone Broth, 2%Hardy MediaJSFClass I
K870640Cetrimide Selective AgarHardy MediaJSIClass I
K870639Bhi with Sheep Blood (5%)Hardy MediaJSGClass I
K870638Bacteroides Bile Esculin AgarHardy MediaJSIClass I
K870637Dermatophyte Test MediumHardy MediaJSJClass I
K870636Hemophilus Id Quad PlateHardy MediaJSHClass I
K870635Regan-Lowe MediumHardy MediaJSJClass I
K870634Tetrathionate BrothHardy MediaKZIClass I
K870420Ptc-6 and Ptc-8 Percutaneous CholangiographyNorth Coast Medi-TekGBZClass I
K870161Model 5000 Micromanipulator Micro CO2 Laser SystemCoherent Medical GroupGEXClass II
K870074Gram Negative and Gram Positive Mic/combo PanelsMicroscan Div. Baxter Healthcare Corp.JWYClass II
K870009Ventrescreen Mite/mold Allergy Test Kit Enzyme Im.Ventrex Laboratories, Inc.DHBClass II
K864602Rubella MicroassayDiamedix Corp.LFXClass II
K863798Fiax(r) Test Kit Cytomegalovirus M AntibodiesWhittaker Bioproducts, Inc.LKQClass II
K871269Ra System, Analyte Serum Amylase (30C and 37C)Technicon Instruments Corp.JFJClass II
K871260Cholesterol DeterminationBiochemical Trade, Inc.CHHClass I
K871244Hood Esophageal ProsthesisHood LaboratoriesESWClass II
K871211Progesterone Clasp Radioimmunoassay KitBiotecx Laboratories, Inc.JLSClass I
K871179Opn XII UlAragona AB Co.ILYClass II
K871071Omega Dorsal Columella ImplantsOmega Silicone, Inc.FZEClass II
K870986Liquid-Stat Iron Reagent Kit & Tibc Reagent KitBeckman Instruments, Inc.JIYClass I
K870972Sonafon, Therapeutic MassagerElectro Medica OfficeIROClass I
K870920Elite ElectrocardiographBurdick Corp.LOS
K870738u.s. Diagnostics Liquid Ck Isoenzyme ControlU. S. Diagnostics, Inc.JJTClass I
K870737u.s. Diagnostics Liquid Ld Isoenzyme ControlU. S. Diagnostics, Inc.JJTClass I
K870552Affinity Digoxin ImmunitBD Becton Dickinson Vacutainer Systems PreanalyticKXTClass II
K870430Pad, Petrolatum & Bismuth Tribromophenate Impreg.Steridyne Laboratories, Inc.FROUnclassified
K864729Neurochemical AnalyzerEsa, Inc.LEQClass I
K871297Kadir Hi-Torque Guide WireArgon Medical Corp.KODClass II
K871210Kotex Profile Shaped Maxi PadKimberly-Clark CorporationHHDClass I
K871190Anadias Zara System Malar ImplantsAnadias, Inc.FWPClass II
K871074Omega Extended Malar and Omega Contoured MalarOmega Silicone, Inc.FWPClass II
K871050Capd Admin. Set Used W/inpersol Capd Biocap Y-Adm.Abbott MedicalKDJClass II
K871049Capd Y-Admin. Set Used W/inpersol Biocap Admin.Abbott MedicalKDJClass II
K871034Lca 2000Vistek Corp.FTAClass II
K870948Model 435-03 Side Hook Implantable Pacing LeadIntermedics, Inc.DTBClass III
K870894Medsurg Bone Marrow Biopsy/aspiration TrayMedsurg Industries, Inc.
K870892Medsurg Percutaneous Aspiration Biopsy (Pab) TrayMedsurg Industries, Inc.FSMClass I
K870873Md Monitoring/diagnostic ElectrodeLectec Corp.DRXClass II
K8707487.5 Mhz Transrectal (Endorectal) ProbePhilips North America LLCITXClass II