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 3296 of 3528
510(k) clearances, page 3296 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K811065Piston SyringeSherwood Medical Co.FMFClass II
K811055Blood Agar Base Ph 7.4Neogen Culture MediaJSGClass I
K811048Macconkey AgarNeogen Culture MediaJSIClass I
K811047Fluid Thioglycollate MediumNeogen Culture MediaJSGClass I
K811046Sterility Test BrothNeogen Culture MediaJSIClass I
K811045Levin Eosin-Methylene Blue AgarNeogen Culture MediaJSIClass I
K811044Triple Sugar Iron AgarNeogen Culture MediaJSHClass I
K811043Bismuth Sulfite AgarNeogen Culture MediaJSIClass I
K811042Xld AgarNeogen Culture MediaJSIClass I
K811041Brilliant Green AgarNeogen Culture MediaJSIClass I
K811040Cetrimede AgarNeogen Culture MediaJSIClass I
K811039Vogel & Johnson AgarNeogen Culture MediaJSIClass I
K811023Root Canal KitDentsply Intl.ELCClass II
K811020Reversible Hydrocolloid ImpressionKottler LaboratoriesELWClass II
K810987Earette Hearing Aid Oticon #E27fOticon, Inc.ESDClass I
K810986Earette Hearing Aid Oticon #E25fOticon, Inc.ESDClass I
K810978Montgomery Silicone Tracheal T-TubeBoston Medical Products, Inc.BTOClass II
K810972The Gnathometer-MBauer, Cheng & Associates, Inc.KZOClass I
K810971The GnatometBauer, Cheng & Associates, Inc.EJPClass I
K810970Isosit TeethBauer, Cheng & Associates, Inc.ELMClass II
K810969Isosit C & B MaterialBauer, Cheng & Associates, Inc.EBFClass II
K810961Campylobacter Med. (Plate)Granite Diagnostics, Inc.JSJClass I
K810899Technicon Autogrouper 16-C SystemTechnicon Instruments Corp.KSZClass II
K810860Eni Antibody to Epstein-Barr VirusElectro-Nucleonics Laboratories, Inc.GNPClass I
K810856Direct Immunofluor. Antibody Test KitBartels Immunodiagnostic Supplies, Inc.GPTClass I
K810837Cyber 80 HemodialyzerCyberex Corp.FJGClass II
K810835Rubazyme - MAbbott MedicalGOKClass II
K810793Mouthpiece, BreathingDhd Medical Products Div. Diemolding Corp.BYPClass I
K810655Disposable Scrub BrushDexide, Inc.GECClass I
K810645Select-a-Flow CollectorWenmar Intl. Corp.KNXClass II
K811100Gelman Electrophoresis ControlGelman Sciences, Inc.JJYClass I
K811087Mika Skin Scrub Tray Pre Operative W/gelCunningham Woodland, Inc.FSMClass I
K811086Suture Removal Set(displsable)Cunningham Woodland, Inc.KDDClass I
K811085Venes IIJung Products, Inc.DWLClass II
K811066Model 230-06 Cyberlith Tm I Bipolar inIntermedics, Inc.DXYClass III
K811060Polyethylene Medullary PlugArthur A. Checchi, Inc.
K811052Tryptic Soy Agar W/lecithin & Tween 80Neogen Culture MediaJSGClass I
K811034Emit-Cad N-Acetylprocainamide AssaySyva Co.LARClass II
K811016Cc-100Anthro-Metrics Corp.DPSClass II
K811001Microerma SystemDynatech Corp.JQWClass I
K810989Ibm 5880 Acquisition & Analysis Cart TelIntl. Business MachinesLOS
K810988Ibm 5885 Digital ECG Acquisition CartIntl. Business MachinesDPSClass II
K810985Antinuclear Antibody ImmunofluorescentImmuno-Products IndustriesDHNClass II
K810984Antimitochondrial Immunofluorescent TestImmuno-Products IndustriesDBMClass II
K810983Antismooth Muscle Antibody Test SysImmuno-Products IndustriesDBEClass II
K810982Antithyroid Antibody ImmunofluorescentImmuno-Products IndustriesJZOClass II
K810920Ndm Diatemp Infant Electrosurg. Disp. P.Ndm Corp.HAMClass II
K810875Fecal Staining KitJayco PharmaceuticalsKKJClass I
K810872EEG Telephone Receiver Model #Afr-JTelediagnostic Systems, Inc.DXHClass II
K810847Pritchard Surface Replacement ElbowDepuy, Inc.JDBClass II