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 3121 of 3528
510(k) clearances, page 3121 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K833306Betatron I Ambulatory Insulin PumpCardiac Pacemakers, Inc.FRNClass II
K833305Vector Seige 2023645 Ac Powered Stimu-Metronex EngineeringLIHClass II
K833291Jh Peptone AgarNeogen Culture MediaJSHClass I
K833286Rx Seg EconoplusGenesis Industries, Inc.EISClass I
K833284Rx 41 Pentron 41Genesis Industries, Inc.EISClass I
K833283Rx Ory Pentron C & BGenesis Industries, Inc.EISClass I
K833282Rx Nysp Pentron 60Genesis Industries, Inc.EISClass I
K833281Rx D PentronGenesis Industries, Inc.EISClass I
K833279Naturelle-LiteGenesis Industries, Inc.EISClass I
K833265Respiratory Flow ModuleThoratec Laboratories Corp.JAXClass II
K833222Sinusvu 2500Radionics Medical, Inc.IYOClass II
K833189Hydroflow Suction Irrigation SystemAbbott MedicalGCJClass II
K833146Aqueous Blood Gas ControlBionostics, Inc.JJSClass I
K833145ZenithJeneric Ind.EJHClass II
K833112Tubing for Cardiopulmonary BypassCardio Med Supplies, Inc.DWFClass II
K833065Automatic Peritoneal Dialysis CyclerTravenol Laboratories, S.A.FKXClass II
K832996Surgical Iop MonitorMiami Eye Technology, Inc.HKYClass II
K832973Tampax Super Deodorant MaxithinsTampax, Inc.HHLClass II
K832972Regular Deodorant Maxithins PadsTampax, Inc.HHLClass II
K832971Deodorant Maxithins Panty ShieldTampax, Inc.HHLClass II
K832925Modification in Membrane Housing ConfiRies BiologicalsKOCClass II
K832875Cordia HsCordis US Corp.GQNClass II
K832845Egerton Turning & Tilting Net Suspen BedKCI USA, Inc.FNJClass I
K832816Hall ArthrotomeAmerican Sterilizer Co.
K832783Micro-Sample Osmometer 3M0Advanced Instruments, LLCJJMClass I
K832756Pri a PusTrans Texas Medical Devices Corp.LKYClass II
K832566Coaxial Electrode #300AK-Med, Inc.FFKClass II
K832558Release of Ethylene Oxide-Steriliz. DevDeseret Medical, Inc.FOZClass II
K832380Protective SleeveVertex Medical Corp.DYGClass II
K832350Intrabionic Co. - Micro SyringeIntrabionic Co.FRNClass II
K832349ProgramedIntrabionic Co.FRNClass II
K832272Tourniquet Cuff Pressure Monitor #TcpmElectromedics, Inc.LDQ
K832149Pdm Siloxane Prosthetic ObturatorDelaware Prosthetics, Inc.
K832148Pdm Siloxane Prosthetic Chin ImplantDelaware Prosthetics, Inc.FWPClass II
K831990Neuroflax, EpkFranks ElectronicsGZJClass II
K831204MultipleDerma-Lock Medical Corp.NADClass I
K833678Hematology Wright's Stain PackJ.S. Medical Assoc.IAFClass I
K833677Quick Stain Wright's Giemsa W/buffJ.S. Medical Assoc.HYFClass I
K833665Hematology Wright's-Giemsa Satin PackJ.S. Medical Assoc.HYFClass I
K833466Early Pregnancy Detection Test KitOrtho-Clinical Diagnostics, Inc.LCXClass II
K833338Tooth SloothJoel Lander D.D.S.EJBClass I
K833159Potassium Electrode Tip Assambly-K-Hi Chem, Inc.CEMClass II
K833156Quidel Hcg Enzyme Immunoassay KitOrtho-Clinical Diagnostics, Inc.JHJClass II
K833153Nova 10 Sodium/potassium/total CalciuNova Biomedical CorporationJJFClass I
K833082Reagent Set Triglycerides GpoBoehringer Mannheim Corp.CDTClass I
K833062Serum Cholinesterase Reagent SetSterling Biochemical, Inc.DLIClass I
K832976Bx-600 EmsBloomex International, Inc.IPFClass II
K832933Gold Film Mercury Analyzer #511Jerome Instrument Corp.DPHClass I
K832928Servo Heated Respiratory HumidifierFisher & Paykel Allied Products, Ltd.BTTClass II
K832898Nebulizer Accessory for Servo VentillSiemens Elema ABCAFClass II