510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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
45,902 of the 176,299 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
20262,502
176,299 records, page 3391 of 3526
510(k) clearances, page 3391 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K791743Weck Rack (Sterilizing Accessory Tray)Edward Weck, Inc.FSMClass I
K791831ProcastMedical Specialties Inc.ITGClass I
K791709Heel/elbow ProtectorsFibre Formations, Inc.FMPClass I
K791708Inorganic Phosphorus ReagentGilford DiagnosticsCEOClass I
K791696Contro IIHi Chem, Inc.JJYClass I
K791695Contro IHi Chem, Inc.JJYClass I
K791679Nadh Oxidation, Ast/sgotAmerican Monitor Corp.CITClass II
K791669Glucose Oxidase Reagent SetMacomb Chemical Co.CGAClass II
K791661System Controller 720 SeriesWaters Assoc., Inc.KIEClass I
K791641Sgpt Reagent Set ModificationAmerican Monitor Corp.CKAClass I
K791640Coulter Accu-Zyme II Enzymatic ReagentCoulter Electronics, Inc.CDTClass I
K791635Ao Teaching Attachment, Model Ta-1American Optical Corp.FEAClass I
K791624Mueller-Hinton AgarAmerican Laboratory Supply, Inc.JTZClass II
K791622Columbia Agar With5% SheepAmerican Laboratory Supply, Inc.JSGClass I
K791621Mannitol Salt AgarAmerican Laboratory Supply, Inc.JSIClass I
K791620Tryptic Soy Agar 5% Sheep BloodAmerican Laboratory Supply, Inc.JSGClass I
K791607Beta-CellBiologics Intl., Inc.JSGClass I
K791571Toxoplasma Antibody Test SystemZeus Scientific LLCGLZClass II
K791560Goat Anti-Human C-Reactive ProteinProtos LaboratoriesDCKClass II
K791495Lukens Bone Wax (Gamma Radiation)Lukens Corp.MTJUnclassified
K791493Anti-Nuclear Antibody TestMeloy Laboratories, Inc.DHNClass II
K791462Hyperdermic Needle with Sensor #514Medtech Intl., Inc.FMIClass II
K791459Agglutinotest-ListeriaVolu Sol Medical IndustriesGSHClass I
K791457Agglutinotest-SyphilisVolu Sol Medical IndustriesGMTClass II
K791456Agglutinotest-ToxoplasmosisVolu Sol Medical IndustriesGMNClass II
K791454Agglutinotest-PertussisVolu Sol Medical IndustriesGOXClass I
K791453Agglutinotest-StaphylolisinVolu Sol Medical IndustriesGTNClass I
K791452Agglutinotest-TuberculosisVolu Sol Medical IndustriesGRTClass I
K791451Agglutinotest-EchinococcosisVolu Sol Medical IndustriesGPFClass I
K791450Agglutinotest-SalmonellaVolu Sol Medical IndustriesGNCClass II
K791449Agglutinotest-BrucellaVolu Sol Medical IndustriesGSOClass II
K791397Herpes Eia Test KitMicrobiological Assoc.GQMClass II
K791322Erika Hpf 300Erika, Inc.FJIClass II
K791321Erika Hpf 200Erika, Inc.FJIClass II
K791320Erika Hpf 100Erika, Inc.FJIClass II
K791301Ortho Tsh Ria KitOrtho Diagnostics, Inc.JLWClass II
K791191The Galassia SystemAriel
K790948Temp-Guard TmGordon Consultants, Inc.FMTClass II
K791806Conphar Adapt-Connects Sterile, Nonste.Conphar, Inc.KGZClass I
K791803Conphar Catheter PlugConphar, Inc.KGZClass I
K791802Conphar Tube ClampsConphar, Inc.GDJClass I
K791801Conphar Fingertip Suction ControlConphar, Inc.JOLClass II
K791800Conphar Umbilical Cord ClampConphar, Inc.GDJClass I
K791762Self CheckInstromedix, Inc.DTCClass II
K791429Emisonic 4290Emi Medical, Inc.IYOClass II
K791192Af/systemAriel
K791181Programmer, Medtronic Model 5984/5985Medtronic, Inc.DXYClass III
K790873Model 221 Programalith Pulse GeneratorPacesetter SystemsDXYClass III
K791799Conphar AirwaysConphar, Inc.CAEClass I
K791781Tube-StrapOlympic Medical Corp.JAYClass I