510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK 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
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 2463 of 3531
510(k) clearances, page 2463 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K905838Strato Port Introducer Kt(10 Fr) Lps 5015/ModifiedStrato Medical Corp.LJTClass II
K905647Jensen III Chiropractic J-TableFreedman, Wolk and Co.INQClass I
K905035Axostim Nerve Stimulator, ModificationSinger Medical Products, Inc.ETNClass II
K904841Lpi Yag Model 1003 Surgical Laser Syst/modifiedLaser Photonics, Inc.GEXClass II
K904616Storz Ultra-Source High Output IlluminatorStorz Instrument Co.HBIClass II
K903046Idt-1104 Implant (Screw-in-Threaded)Minimatic Implant TechnologyDZEClass II
K903043Ict-1108 Implant- Threaded (Cement Type Abutment)Minimatic Implant TechnologyDZEClass II
K902613Bard Pca II Pump with Program CartridgesC.R. Bard IncFRNClass II
K911346Sophycamera Dsx BodytrakSopha Medical Systems, Inc.IYXClass I
K911303Antimicrobial AmikacinAlamar Biosciences Laboratory, Inc.JWYClass II
K911181Intimax(tm) Irrigation CatheterApplied Vascular Devices, Inc.GCAClass II
K911146Tan Chong Glove, HypoallergenicBoston Medical Corp.LYYClass I
K911048Model 5857-3M Lead End Cap KitMedtronic, Inc.DTDClass II
K910862Various Template ApplicatorsBest IndustriesIWJClass I
K910855Endopath Veress NeedleBoston Scientific CorporationFHPClass II
K910630Model 6985M Temporary Unipolar Lead Extender KitMedtronic, Inc.DTDClass II
K910521System 7300 Pulse OximeterAdvanced Medical Instruments, Inc.DQAClass II
K910270Premixed Dialysate for HemodiafiltrationBaxter Healthcare CorporationKPOClass II
K910259Schneider Magnarail Probing CatheterSchneider Intl., Ltd.DQOClass II
K910254Diagnostic Hysteroscopy Redikit (Tm)CooperSurgical, Inc.HHEClass II
K910253Leep RedikitCooperSurgical, Inc.HEEClass II
K905528Uresil Valve CutterUresil, LLCDWQClass II
K905236Ipv Percussionator Family & Related AccessoriesPercussionaire Corp.NHJClass II
K904953Planmed SophiePlanmeca U.S.A. IncIZHClass II
K904783Discrete Photometric Chemistry AnalyserIndustrial Chemical MeasurementJJQClass I
K897132Pathway II ElectromyographThe Prometheus GroupHCCClass II
K911511Alastat Allergen Specified Ige System, ModifiedSiemens Healthcare Diagnostics Inc.DGOClass II
K911225Tray DoughThe Hygenic Company, LLCKGSClass I
K911211Phonak 9100 Sc-Af Ite Hearing InstrumentPhonak, Inc.ESDClass I
K911210Phonak 9800 Sc-Af Ite Hearing InstrumentPhonak, Inc.ESDClass I
K911187Antimicrobial CefuroximeAlamar Biosciences Laboratory, Inc.JWYClass II
K911186Antimicrobial Ampicillin/sulbactamAlamar Biosciences Laboratory, Inc.JWYClass II
K910832Oxyfresh Oxycare 3000OxyfreshEFSClass I
K910816In-Sight Surgical Instrument Kits, DisposableInsight International, Inc.KDDClass I
K910509Patient Gas Sampling Line for Ohmeda 6000Intertech Resources, Inc.CCKClass II
K910243Mobile Treatment CartJEDMED Instrument CompanyETFClass I
K905304Dresser Argus P/n 1818Dresser Argus, Inc.BTMClass II
K905257Opus Cmv Test SystemPb Diagnostic Systems, Inc.LINClass II
K904876Dw237Ivoclar North America, Inc.EJSClass II
K903099Quidel Helicobacter Pylori TestOrtho-Clinical Diagnostics, Inc.LYRClass I
K902420Catheter, Nasal, OxygenGainor Medical Europe, Ltd.CATClass I
K900197The Max System, Model: Basic, 1000,2000 AudiometerSound Linked Data, Inc.EWOClass II
K894227Allergen Modules for Alastat TmSiemens Healthcare Diagnostics Inc.DHBClass II
K911468Rep Spe Plus (Acid Blue) SystemHelena Laboratories, Corp.CEFClass I
K911448Multiple Biopsy Device-MbxTriton Technology, Inc.FCKClass II
K911447Latex Examination Gloves (Hypoallergenic)Aladan Corp.LYYClass I
K911409Opus FshPb Diagnostic Systems, Inc.CGJClass I
K911339Shimadzu X-Ray High-Voltage Generator Xud150kShimadzu Medical SystemsIZOClass I
K911297Chloride ReagentIntersect Systems, Inc.CHJClass II
K911094Inpersol Capd Biocap Administration SetAbbott MedicalKDIClass II