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 3119 of 3528
510(k) clearances, page 3119 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K833503Clirans Model Taf 15 Hollow FiberTerumo Medical Corp.KOCClass II
K833475Capiject Sys Capillary Blood CollectTerumo Medical Corp.JKAClass II
K833440Blood Safety Module Bsm2Hospal Medical Corp.KOCClass II
K833423Ventrezyme Eia Controls-ImmunoassayVentrex Laboratories, Inc.JJYClass I
K833333In the Ear Hearing Aid Omni 100Omni Hearing SystemsESDClass I
K833320Amberlite Cg50 Resin, 100-200 MeshBiosan Laboratories, Inc.KEAClass I
K833312Arterial Micro Collection KitCurrent Technologies, Inc.JKAClass II
K833257Wako Glucose CFUJIFILM Healthcare Americas CorporationCGAClass II
K833237Digital Radiography Sys Dual GantriesAmerican Science and Engineering, Inc.JAAClass II
K833192Normal Urine ControlBiosan Laboratories, Inc.JJYClass I
K833191Abnormal Urine ControlBiosan Laboratories, Inc.JJYClass I
K833157Lancer Analyzer CupsSherwood Medical Co.JJCClass I
K833154Nova 9 Sodium/potassium/total CalciumNova Biomedical CorporationJJFClass I
K833152Metavox Mv-1000 Hearing AidMetavox, Inc.ESDClass I
K833143Rexillium IIIJeneric Ind.EJHClass II
K833140Thyroid Uptake SystemAdvanced Medical Research Corp.IZDClass I
K833067Impact 400 #1447X2GilfordJJEClass I
K833045Clinical TympanometerAmerican Electromedics Corp.ETYClass II
K832895Vision Two, One/10 One/20 &24Comtal Corp.LLZClass II
K832886Flame Photometer T281-T282-T283Texas Intl. Laboratories, Inc.JJOClass I
K832801Oreia II B-Hcg, Enzyme InnunoassayOrganon LLCJHIClass II
K832752Comfort Cushion Dispos. AnalgesisMission Dental, Inc.CBNClass II
K832717Diagnon B12 57Co Ria KitDiagnon Corp.CDDClass II
K832677P-S Medical Berlin Visaduct KitPudenz-Schulte Medical Research Corp.KOAClass I
K832883Mini-PecgIntersect Systems, Inc.DPSClass II
K832882Dif-StetIntersect Systems, Inc.DQDClass II
K833482Wisdom AirwayWisdom Corp.CAEClass I
K833274Dermatology Handpiece-Ophth LaserSynemed, Inc.HQFClass II
K833857Maclean-Fogg, Tissue CassettesPolymer Technology Corp.IDZClass I
K833824Endocardial Screw-in Lead 859 & 861Pacesetter SystemsDTBClass III
K833823Holter Performer Feather Weight/cassApplied Cardiac SystemsDSHClass II
K833809Neural Stimulator MonitorInstromedix, Inc.GZBClass II
K833798Optima Mdt Pulse Generator W/telemetryTelectronics, Inc.DXYClass III
K833507Prepared Tryptic Soy Agar 100 Mm PlateLavco Laboratory, Inc.JSGClass I
K833506Prepared Mueller Hinton Med/100 MmLavco Laboratory, Inc.JTZClass II
K833298Audit V Ax 135Axonics, Inc.GWKClass II
K833271Namic Continuous Flush DeviceNorth American Instrument Corp.DRSClass II
K833253Shiley M2000 Membrane OxygenatorShiley, Inc.DTZClass II
K832374Photoflo Dual-Mode PhotoplethysmographSonicaid, Inc.JOMClass II
K832227G-2000Eaton Medical GroupDPSClass II
K831676Biosensor Asc SystemBiosensor Corp.DSIClass II
K831164Patient Monitor Cm 135Honeywell, Inc.DRTClass II
K833178Solution Administration Line W/spikeIntramed, Inc.FPAClass II
K833880Telephonic Receiver R-10 EEGPharmaquest Corp.GYEClass II
K833870Knee WalkerMaddak, Inc.IONClass I
K833869Child's WalkerKaye Products, Inc.ITJClass I
K833840Massator-PedioTrileen, Inc.ISAClass I
K833692Fraser Harlake Dental Anti-Polution SysFraser Harlake, Inc.CBNClass II
K833690Coaxial Balloon Urethral DilatorAmerican Edwards LaboratoriesFAAClass III
K833659IV Extension SetDna Medical, Inc.FPKClass II