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 3457 of 3526
510(k) clearances, page 3457 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K780034Autoclave Pouches&rolls/steam&gasE.M. Adams Co., Inc.FRGClass II
K780033Mattresses, Conductive & CoversChase Mfg. Co.FMWClass I
K780023Black Bag, ElectronicMarshall Electronics, Inc.LDEClass I
K780014Cold Cycle, Chemical Cold PackSignal WestIMDClass I
K772403Cut-Down Built-Up Toilet SeatFred Sammons, Inc.LDQ
K772334Monitor, Cardiac, W/blood Press.&tempTelectronics, Inc.DSKClass II
K780241Compression MultisonicQualitoneESDClass I
K780226Spreader BarsZimmer GmbHILZClass I
K780213Handpiece, Lift, EndoKerr Corporation (Danbury)EGSClass I
K780138Ek-670Burdick Corp.DPSClass II
K7802114-in-1 Disp. Crown & Bridge TrayKerr Corporation (Danbury)EHYClass I
K780205Orthodontic Buccal TubeRocky Mountain Orthodontics, Inc.DZDClass I
K780199Prophy Angles, R&rRansom & Randolph. LLC.EGSClass I
K780198Prophy Cups, R&rRansom & Randolph. LLC.EHKClass I
K780194Toe LoopsOrthopedic Equipment Co., Inc.KNOClass I
K780193Heel LoopsOrthopedic Equipment Co., Inc.KNOClass I
K780192Legrest, ElevatingOrthopedic Equipment Co., Inc.KNNClass I
K780191Strap, LegrestOrthopedic Equipment Co., Inc.KNOClass I
K780101Ultrazyme Plus LdhHarlecoCFJClass II
K780072Glucose Reagent SetMedical Analysis Systems, Inc.CFRClass II
K780071Gama-Gpt Reagent SetMedical Analysis Systems, Inc.JQBClass I
K780069Bun Reagnet SetMedical Analysis Systems, Inc.CDQClass II
K780062Catheter/hemostatic/geriatricKendall Research CenterEZLClass II
K780184Wheelchair AccessoriesOrthopedic Equipment Co., Inc.IMXClass I
K780183Wheelchairs, MechanicalOrthopedic Equipment Co., Inc.IORClass I
K780182Tobramycin 125I Ria KitNew England NuclearDIDClass II
K780178Test Sys. for Ndna Antibody Determ.Zeus Scientific LLCDHNClass II
K780169Mask, SurgicalConvertorsFXXClass II
K780159AnaswabScott Laboratories, Inc.JTXClass I
K780157Radiation Treatment Planning SystemMirion Technologies (Capintec), Inc.JADClass II
K780150Neonatal Screening AudiometerTelediagnostic Systems, Inc.EWOClass II
K780113Cardiac Pulse Generator, Model 160BTelectronics, Inc.DXYClass III
K780104Ultrazyme Plus HbdHarlecoJMKClass I
K780103Ultrazyme Plus GotHarlecoCITClass II
K780102Ultrazyme Plus GptHarlecoCKAClass I
K780095Ultrazyme Plus AlpHarlecoCJEClass II
K780094Iron Binding Capacity ChemistryHarlecoJMOClass I
K780093Glucose Reagent for Glucose AnalyzerHarlecoCGAClass II
K780079Cannula, Artery, RenalDravon Medical, Inc.DQRClass II
K780074Ldh-L Reagent SetMedical Analysis Systems, Inc.
K780073Hbdh Reagent SetMedical Analysis Systems, Inc.JMKClass I
K780070Cpk Reagent SetMedical Analysis Systems, Inc.CGSClass II
K780059Rabbit Antibody/thyroid Stimul. HormonePcl-Ria, Inc.JLWClass II
K780050Thyroxine Stds. in Human SerumPcl-Ria, Inc.CDXClass II
K780043Esis ModuleDatascope Corp.DRRClass II
K772422Quantimune Digoxin Ria/digoxin RiaBio-RadDONClass II
K772404Finger Exercise BoardFred Sammons, Inc.IONClass I
K772333Recorder, Paper, ECGTelectronics, Inc.DSFClass I
K772332Monitor, Cardiac, BedsideTelectronics, Inc.DRTClass II
K780161Immunoperoxidase Test Sys. for Ana SeterZeus Scientific LLCDHNClass II