510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
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 3059 of 3528
510(k) clearances, page 3059 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K842823Chermel OsteotomesCher Mel Corp.GFIClass I
K842822Chermel Bone GougesCher Mel Corp.GDHClass I
K842800Montg. Laryngeal KeelBoston Medical Products, Inc.FWNClass II
K842702Rosenberg Skin Grafting KnivesDowns Surgical, Ltd.GFDClass I
K842701Hoppenstein Microsurgical Spinal InstruDowns Surgical, Ltd.FZSClass I
K842699Islam Bone Marrow Aspiration NeedlesDowns Surgical, Ltd.GAAClass I
K842683Genetic Sys Legionella ImmunofluroresGenetic Systems Corp.LHLClass II
K842623Microtrak Chlamydia Trachomatis DirectSyva Co.LJPClass I
K842551Base Metal AlloyDentsply Intl.EJHClass II
K842522Pda SystemAbbott MedicalJJGClass I
K842515Surgical HeadlightGood-Lite Co.EBAClass I
K842463Gx CephGendex Corp.EAGClass II
K842453Disposable Preping PadAnago, Inc.
K842438Disposable Surgery HoodAnago, Inc.
K842433Allied Assoc. Therapeutic ExerciseAllied Associates, Inc.BXBClass I
K842430Allied Assoc. Therap. Exercise EquipAllied Associates, Inc.BXBClass I
K842429Allied Assoc. Therapeutic Exer Equip-Allied Associates, Inc.BXBClass I
K842330Amer. Histo-Id Sys Primary Iga 2720-21Bartels Immunodiagnostic Supplies, Inc.CZPClass II
K842329Amer. Histo-Id Sys Primary Igg S7920-11Bartels Immunodiagnostic Supplies, Inc.DEWClass II
K842327Amer. Histo-Id Sys Primary Igm S7920-31Bartels Immunodiagnostic Supplies, Inc.DFTClass II
K842326Amer. Histo-Id Sys Primary KitBartels Immunodiagnostic Supplies, Inc.DFHClass II
K842315Ultra Lyte Analyzer I 100Ultra Quest Diagnostics, Inc.CEMClass II
K842293Partially Threaded Bone Fix. PinWarsaw Orthopedic, Inc.JDWClass II
K842215Ascorbic AcidbioMerieux, Inc.FIPClass II
K842054Cobe AepsCobe Laboratories, Inc.KRLClass II
K841763Woodlyn Slit Lamp Hssl-EcWoodlyn, Inc.HLIClass II
K841762Woodlyn Applanation TonometerWoodlyn, Inc.HKXClass II
K841735Acu-Derm Transparent Incise DrapeAcme United Corp.KKXClass II
K841611Quinton 901 & 900 Holter ScannerQuinton, Inc.DPSClass II
K841362Tidal Distension Irrigation SetAbbott MedicalGBXClass I
K840907Post-AidE.W. Link, Inc.KCMClass I
K840893Conferette C2Siemens Hearing Instruments, Inc.ESDClass I
K840652Prism-FineDentsply Intl.
K840096SebutapeCuderm Corp.
K833369Early DetectorWarner-Lambert Co.KHEClass II
K842805Impuls 3, It SelectorRobert Bosch Corp.ISBClass II
K842802Vacomed 4Robert Bosch Corp.ISAClass I
K842801Ultramed 11S601Robert Bosch Corp.IMJClass II
K842704Mt-700 Mt-750 Ft-350Cryomedics LLCGEHClass II
K842545All-Hands Sterile Field-0201All-Hands Medical Supply, Inc.KKXClass II
K842432Allied Associates Therapeutic ExersieAllied Associates, Inc.BXBClass I
K842431Allied Assoc. Therap. Exercise Equip-Allied Associates, Inc.BXBClass I
K842428Allied Assoc. Therapeutic Exercice EquipAllied Associates, Inc.BXBClass I
K842427Allied Assoc. Therapeutic Exercise EquipAllied Associates, Inc.BXBClass I
K842426Allied Assoc. Therapeutic ExericseAllied Associates, Inc.BXBClass I
K842425Allied Associates Therapeutic ExerciseAllied Associates, Inc.BXBClass I
K842335Pillow W/staphchek TickingMonterey Mills, Inc.KMEClass I
K842304The PathfinderHydro-Med Products, Inc.
K842259Pci W/cath-Seal Side Flow FittingUniversal Medical Instrument Corp.DYBClass II
K842084Axiom Femoral Venus CatheterAxiom Medical, Inc.DQYClass II