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 3120 of 3528
510(k) clearances, page 3120 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K833651Clip Applying ForcepsAdvanced Biosearch Assn.HCIClass II
K833648Ophthalmic Cautery #6821-Hot-Temp #'SEdward Weck, Inc.HAMClass II
K833622Renalloy Hemasite Vascular Access ShuntRenal Systems, Inc.FIQClass II
K833595Capd Ultraviolet Germicidal ExchangeTravenol Laboratories, S.A.FKXClass II
K833500Max 02 Oxygen ConcentratorMountain Medical Equipment, Inc.CAWClass II
K833495Bunn Micro Oxygen ConcentratorGreene & Kellogg, Inc.CAWClass II
K833493Disposable Syringes & NeedlesAldrich Chemical Co., Inc.FMFClass II
K833492Percutaneous Endoscopic GastroscopyAmerican Endoscopy, Inc.KNTClass II
K833452Ohio Gms AbsorberAirco/Ohio Medical ProductsBSFClass I
K833449Hand Controlled Pencil or Switch HandCameron-Miller, Inc.GEIClass II
K833441Dry GelConcept, Inc.GEIClass II
K8333643M Scotchplate II Dispersive Electrode3M CompanyGEIClass II
K833244ReviveAladdin Industries, Inc.BTMClass II
K833236Telephone Transmitter T-10 EEGPharmaquest Corp.GYEClass II
K833224Bifocal 3.0MhzAdr UltrasoundITXClass II
K833200Tricon M Total Knee SystemRichards Medical Co., Inc.MBVClass II
K833124Hobbs Medical Retrieval BasketHobbs Medical, Inc.OCZClass II
K833037Pointer F-3Petra Intl. Co.GZJClass II
K832606Windsor Medical Various ModelsWindsor Medical, Inc.FRNClass II
K832544SystenetAmerican Intl. Medical Supply Co.KGXClass I
K832509Mbs Hard Tissue Replacement SystemMedical Biological Sciences, Inc.LYCClass II
K830197Transcutaneous Blood Oxygen Sensor SysDiamond Shamrock Corp.KLKClass II
K833868Ipos G.l.p. SystemIpos LuneburgKFXClass II
K833835Gentle Flow Breast PumpEklund & Co.HGYClass I
K833682Primary Piggyback Infusion Set W/permCosmetic Sciences, Inc.LDRClass II
K833661Electrocardiocorder Recorder 453Del Mar AvionicsDSHClass II
K833660Preserv Pva Fixative -Malin PackPreventive Diagnostics Corp.KDTClass I
K833653D-LyteDialysis Products, Inc.KOCClass II
K833631Thermamed BathBernlit Enterprises, Inc.IMCClass II
K833628Lumen-4 Urodynamic CatheterSurgitekFAPClass II
K833625Active LifeConvatec, A Division of E.R. Squibb & SonsEXBClass I
K833624Shutt Universal Stress PostConcept, Inc.FWZClass I
K833621Entri Flex Feeding TubeBiosearch Medical Products, Inc.KNTClass II
K833591Feeding TubeMedovations, Inc.KNTClass II
K833564Hot/ice Disposable BlanketThermo Temp, Inc.ILOClass II
K833549Pdi Surgical Scrub/brush T150-70Nice-Pak Products, LLCNABClass I
K833542Surgical InstrumentHirata Sangyo Co. USA, Inc.GENClass I
K833541Surgical InstrumentHirata Sangyo Co. USA, Inc.GADClass I
K833513Needle Catheter Jejunostomy KitBiosearch Medical Products, Inc.KNTClass II
K833509Chemonucleolysis TableStryker Corp.FWYClass I
K833488SonicompSonicaid, Inc.HEMClass II
K833469Fpc Fecal Parasite ConcentratorEvergreen Scientific, Inc.LKSClass I
K833460Syringe,piston Needle, Hollow LumenAldrich Chemical Co., Inc.FMFClass II
K833417Endoscopic RetrogradeMicrovasiveODDClass II
K833413Computerscope Cps-AbrRc Electronics, Inc.GWLClass II
K833397Tri-Med 511 Infant Respiration MonitorTri-Med, Inc.CCKClass II
K833370Linear Vibration a Mcshirley ProductMcshirley Products, Inc.IROClass I
K833354Auto-TENS Model VI Dual Channel BattPhysio Tronics Corp.GZJClass II
K833337Volurex IIDhd Medical Products Div. Diemolding Corp.BWFClass II
K833327Respironics Pr ValveRespironics, Inc.BSKClass II