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 3419 of 3526
510(k) clearances, page 3419 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K790177Ashtray for WheelchairFred Sammons, Inc.KNOClass I
K790176Adjustable Height Desk Arm Lap Tray KitFred Sammons, Inc.KNOClass I
K790174Bk-6021 Condom Catheter HolderFred Sammons, Inc.KNXClass II
K790171Bk-2084 Plastic Sock and Stocking AidFred Sammons, Inc.ILDClass I
K790160Oxygen Tubing, W/vinyl and Latex TipsAirlife, Inc.BYXClass I
K790159Corrugated Flexible E.v.a. TubingAirlife, Inc.BYXClass I
K790158Tubing, E.v.a. FlexibleAirlife, Inc.BYXClass I
K790147Tubing CorrugatedAirlife, Inc.BYXClass I
K790125Ulnar Head ProthesisCutter Laboratories, Inc.KXEClass II
K790124Graft TunnelerNarco ScientificDWSClass I
K790116Cardiotomy Reservoir Cr-2000Delta Medical IndustriesDTBClass III
K790114Electrocardiograph, Ek-9Burdick Corp.DPSClass II
K790086Needle, Trucare VacutainerBD Becton Dickinson Vacutainer Systems PreanalyticFMIClass II
K790043Tracor, Cannula, Bicepts BipolarHalyard HealthHINClass II
K790030Fluid, Rhemox-Hb LysingSysmex CorporationGKRClass II
K790027Shaker, Model Sh-510Sysmex CorporationJRQClass I
K790026Analyzer, Model Cc-720Sysmex CorporationGKLClass II
K790020Serum, Lactic DehydrogenaseFisher Scientific Company L.L.C.CFJClass II
K790014Bipolar, Stanicor Lambda Model 236,235Cordis US Corp.DXYClass III
K782171Seracon-HdlBhp Diagnostix, Inc.JJXClass I
K782149Pulse Generator, Implantable CardiacTelectronics, Inc.DXYClass III
K782106Coagulator, Model 40 AargonLasertek OyHQFClass II
K782038Seracon-CBhp Diagnostix, Inc.JJYClass I
K782037Seracon-aBhp Diagnostix, Inc.JIXClass II
K781965Laser Coagulator, Model 41AkLasertek OyHQFClass II
K781961Control Strip for Visual UrinalysisMiles Laboratories, Inc.JJWClass I
K781904Ria Kit, Quantitope IgeKallestad Laboratories, Inc.DGCClass II
K781824Electrode, Model 030-324/4 GuageTelectronics, Inc.DTDClass II
K781823Electrode, Model 030-326Telectronics, Inc.DTDClass II
K781822Electrode, Model 030-324Telectronics, Inc.DTDClass II
K781792Pressurizer, Exeter CementHowmedica Corp.KIZClass I
K782137Medtronic Model 3797 ElectrodeMedtronic, Inc.GXYClass II
K790217Generator, Model Vg-1Street Electronics Corp.GWEClass II
K790165Oxygen Mask-High ConcentrationAirlife, Inc.BYGClass I
K790164Oxygen Mask RebreatherAirlife, Inc.BYGClass I
K790146Mask, PercentoAirlife, Inc.BYFClass I
K790123Stimulator, Battery PoweredIntermedics, Inc.BXNClass II
K790066Mouthpiece, UniversalAirlife, Inc.BYPClass I
K790063Drill, Cordless SurgicalRichard'S Medical Equip., Inc.KIJClass I
K790057Catheter, OxygenMEDLINE INDUSTRIES, LP - NorthfieldBZBClass I
K790056Cannulas, Dynacor's Nasal OxygenMEDLINE INDUSTRIES, LP - NorthfieldCATClass I
K781916Flext-ThermE-Z-EM, IncKXZClass III
K790157Trach T AdapterAirlife, Inc.BZAClass I
K790155Ventilator Elbow W/suction PortAirlife, Inc.BZAClass I
K790150Bird Drive Line AdaptorAirlife, Inc.BYXClass I
K790149Mask Intulation AdaptorAirlife, Inc.BZAClass I
K790148Cuff ConnectorAirlife, Inc.BZAClass I
K790130Scale, Digital ChairAcme Medical Scale Co.FRIClass I
K790107Catheter Tubing ModificationJelco LaboratoriesDQOClass II
K790087Lubricant, Otrho PersonalOrtho Pharmaceutical Corp.KMJClass I