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 3449 of 3526
510(k) clearances, page 3449 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K780676Sterile Closed SystemMEDLINE INDUSTRIES, LP - NorthfieldKODClass II
K780675Sterile 100% Silicone Foley CatheterMEDLINE INDUSTRIES, LP - NorthfieldKODClass II
K780651Ultrasonic Diagnostic TransducerHoffrel Instruments, Inc.ITXClass II
K780605Isolation GownAbco Dealers, Inc.FYCClass II
K780590Shoe CoversAbco Dealers, Inc.FXPClass I
K780572Dcg Preamplifier ModuleC-V Monitors Corp.DRRClass II
K780571Blood Pressure ModuleC-V Monitors Corp.DRQClass II
K780529Myocath KitSorensen ResearchDQOClass II
K780519Filter TubeJelco LaboratoriesBSNClass II
K780487Fetal Monitoring SystemSonicaid, Inc.HFOClass II
K780345Photocoagulator LaserCavitron Corp.HQBClass II
K772424RyuseiErcona Corp.BWJClass II
K772393Carroll Tendon RetrieverEdward Weck, Inc.GENClass I
K780615Blood Culture MediaMeda Stat Diagnostics, Inc.JSHClass I
K780499Cbr-T3ria KitClinical BioresearchCDPClass II
K780699Earette Hearing AidOpticon Corp.ESDClass I
K780697Goat Anti-Influenza Antisera AtexasNortheast Biomedical Labs., Inc.GNSClass I
K780696Goat Antiinfluenza Antisera AussrNortheast Biomedical Labs., Inc.GNSClass I
K780683Tissue PulsatorPulsator Corp.ISAClass I
K780669Heating Aids-Model C78a & C78bCircle Hearing Instruments, Inc.ESDClass I
K780667Hearing Aid-Model 2010Radioear Corp.ESDClass I
K780645Hmd-2000 Battery-Powered Mini-Drill, theMedishield, Inc.KIJClass I
K780642Litecast SolderWilliams Gold Refining Co., Inc.EJHClass II
K780639Emit Centrifichem Thyroxine AssaySyva Co.CDXClass II
K780631Ndm Infant ECG PackpadNew Dimensions in Medicine, Inc.GYBClass II
K780592Transfer PipetAbco Dealers, Inc.
K780512Auto/stat KitPierce Chemical Co.CGAClass II
K780508Quantitope 125I-Folate Radioassay KitKallestad Laboratories, Inc.CGNClass II
K780507Serum Glutamic-Pyruvic TransaminaseGamma Enterprises, Inc.CKCClass I
K780506Carbon Dioxide ReagentsGamma Enterprises, Inc.KMSClass II
K780505Serum Glutamic-Oxaloacetic-TransaminaseGamma Enterprises, Inc.CITClass II
K780504Creatine Phosphokinase (Cpk)Gamma Enterprises, Inc.JHSClass II
K780500Cbr-T3 Uptake KitClinical BioresearchKHQClass II
K780482Kova Trol IIIIcl ScientificJJWClass I
K780464Lelective Kinetic System-60Hycel, Inc.JJEClass I
K780410Blood Pump-Mode S10k3M Health Care, SarnsFIRClass II
K780372Cre. Phosphokinase Isoenzymes, Rea. Sys.Abbott Medical
K780263ShieldLorvic Corp.EJKClass II
K780214Hemo FecBoehringer Mannheim Corp.KHEClass II
K780173Lypoprotein Cholesterol Test KitEnvironmental Chemical SpecialtiesJHMClass I
K780678Impression TrayRocky Mountain Orthodontics, Inc.EHYClass I
K780654Hearing Aid, EaretteOticon, Inc.ESDClass I
K780646Air-Pwoered ColdrillMedishield, Inc.EKXClass I
K780644Radioassay for Total Serum ThyroxineNuclear Diagnostics, Inc.CDXClass II
K780640Dry Silver Processor Model 1226Honeywell, Inc.DSFClass I
K780625Unistat OximeterAmerican Optical Corp.DQAClass II
K780567Aortic PumpEthicon, IncDWSClass I
K780530Automated Physiologic ProfilerBD Becton Dickinson Vacutainer Systems PreanalyticDQKClass II
K780526Cryptococcal Antigen Latex Agg. SystemI M, Inc.GMDClass II
K780518Ultranovar, Dental u.v. Curing LampDemetron Research Corp.EBZClass II