510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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
46,132 of the 176,529 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
20262,732
176,529 records, page 2414 of 3531
510(k) clearances, page 2414 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K914627Platinum Foil Platinum Miling WaferMetalor Dental USA Corp.EJSClass II
K914529Softshield(tm) 12, 24, 72 Collagen Corneal ShieldsOasis Medical, Inc.MOEClass I
K914394Back MasterProgressive Electrical TherapeuticsBXBClass I
K914384Medical Designs Reusable Carbon Rubber ElectrodeMedical Design & Manufacturing Corp.GXYClass II
K914368Part 872 Degufill H & Degufill M DaDegussa AGEKJClass I
K914341Mixomat AmalgamatorDegussa AGEFDClass I
K914340Duomat 3 AmalgamatorDegussa AGEFDClass I
K914117Landers High Refractive Index Vitrectomy Lens SetOcular Instruments, Inc.HJKClass II
K914076Mdt/castle 2000 Surgical LightsMdt Corp., Inc.FSYClass II
K913981Rich-Mar Model II UltrasoundRich-Mar Corp.IMIClass II
K913860Ultracrown(tm) Pd Alloy Post-SolderDentsply Intl.EJSClass II
K913704Argebond 80Argen Precious Metals, Inc.EJSClass II
K913695Nellcor(r) N-180 Pulse OximeterNellcor, Inc.DQAClass II
K913649Modular Calcar ReplacementZimmer GmbHJDIClass II
K913632Bateman Upf-III Bipolar Endoprosthesis SystemKirschner Medical Corp.KWYClass II
K913629Johnson and Johnson Power SystemJohnson & Johnson Orthopaedics, Inc.HSZClass I
K913583Conversil Fl and Conversil PWilde-USA, Inc.ELWClass II
K913464Stomavision (Stv)Trophy RadiologieEIAClass I
K913291Model C386 Isolette(r) Infant IncubatorAir-Shields, Inc.FMZClass II
K912992Keralloy Non-Gamma 2 AmalgamWilde-USA, Inc.EJJClass II
K912463Micro-QQuantitative Medicine, Inc.GZJClass II
K912460Q-TENSQuantitative Medicine, Inc.GZJClass II
K912247Universal Coupler, Laparoscopic AccessoryLaser Engineering, Inc.GCJClass II
K912203Ems Single Use Manual ResuscitatorsEngineered Medical Systems, LLCBTMClass II
K911179Verres Needles 5 & 6 InchesNorthgate Technologies Inc.HIFClass II
K914677Model Dlase 500 Nd:yag Lase Sys:intra Sft Tis SurgSunrise Technologies, Inc.GEXClass II
K914196Rondex Masks Models 9015/9011/901102 ModifiedRondex Products, Inc.BTMClass II
K914195Rondex CPR Non Rebreathing Valve #9030, ModifiedRondex Products, Inc.CBPClass II
K914046The Big Easy Y-AdapterMicrovena Corp.DYBClass II
K913816Origineedle, ModificationOrigin Medsystems, Inc.FHOClass II
K913371Total Iron and Unsat Iron Bind Capac/iron Bind CalCreative Laboratory Products, Inc.JITClass II
K913312Helix Shaped Coils with Dacron Fibers, ModifiedTarget TherapeuticsHCGClass II
K912775Sapphire 4Me Emg/ep SystemMedelec Intl. Corp.GWFClass II
K911779Helix Shaped Coils with Dacron Fibers, ModifiedTarget TherapeuticsHCGClass II
K911103Danby D.s.p. Syringe PumpIsys Medical, Ltd.FRNClass II
K914628Pyne/chemo-Touch, Ultra-Shield, Pyne-Sterie, ModifMedical Resources, Ltd.LYYClass I
K914609Triglycerides Reagent SetSterling Diagnostics, Inc.CDTClass I
K914568Model Dlaser 1000 Nd;yag Laser SystemSunrise Technologies, Inc.GEXClass II
K914472Spiked WasherSynthes (USA) Products LLCHTNClass II
K914339Dentomat 3 AmalgamatorsDegussa AGEFDClass I
K914200Vascumap Medical Air PlethysmographCarolina Medical ElectronicsDSBClass II
K914100StethoscopeAtlas Medical Products LLCLDEClass I
K914066Electrosurgical Cutting/coagulation Device/accessLaparomed Corp.GEIClass II
K913938Opus(r) Lh Test SystemPb Diagnostic Systems, Inc.CEPClass I
K913835Snowden-Pencer Insufflator Tubing SetSnowden-PencerHIFClass II
K913776Patient Examination GlovesP.T. Irama Dinamika LatexLYYClass I
K913743Il Test(tm) PhencyclidineInstrumentation Laboratory Co.LCMUnclassified
K913742Il Test(tm) OpiateInstrumentation Laboratory Co.DJGClass II
K913738Il Test(tm) AmphetamineInstrumentation Laboratory Co.DKZClass II
K913685Unicath Ep.Xre Corp.IZIClass II