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 2105 of 3531
510(k) clearances, page 2105 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K950900Olympus Igm Immunoturbidimetric ReagentOLYMPUS Corporation of the AmericasCFQClass II
K950707N Latex FerritinBehring Diagnostics, Inc.DBFClass II
K941675Tdp the Special Electromagnetic Therapeutic ApparatusC.M.D. Acupuncture Center & Herbs StoreILYClass II
K941596Remedi Hs Drug Profiling SystemBio-RadDNIClass II
K951173Manual Surgical Instrument for General UseUnited States Surgical, A Division of Tyco HealthcGCJClass II
K951127Hewlett-Packard Model M1026a Anesthetic Gas ModuleHewlett-Packard Co.CCKClass II
K951126Drager Medical Air CompressorDrager, Inc.BTLClass II
K951093Kab SystemKing Systems Corporation.BSFClass I
K951092Catheter Securement DeviceBaxter Healthcare CorporationBSOClass II
K951051Rite-Bite Biopsy ForcepsMill-Rose LaboratoryEOQClass II
K950964Karl Storz Intra-Handpieces and AccessoriesKarl Storz Endoscopy-America, Inc.ERLClass II
K950836Redfield Infrared CoagulatorHogan & HartsonKNSClass II
K950701Wahl Sports Relief Hot/cold Massager RollerWahl Clipper CorpIMAClass I
K950631Id400 Series ArmboardsImage Diagnostics, Inc.JAAClass II
K950460Gold Cd Ultra Mini CanalElectone, Inc.ESDClass I
K950459Gold K Amp Ultra Mini CanalElectone, Inc.ESDClass I
K950412Curagel Hydrogel Wound DressingKendall Healthcare Products Co. Div.Of Tyco HealthNAEClass I
K950351Cl-5500 (Unmodified Device) Precision Curing Unit (Pcu) (Modified Option)Ion Laser TechnologyGEXClass II
K950350Themalator. Models T-4-S, T-8-S, Etc.Whitehall/Div Columbus Mckennon Corp.IRQClass I
K950344Horizon Foley Catheterization Tray without CatheterAcacia Laboratories, Inc.FCMClass II
K950313Kaplan Pendulaser 115 - a 15W CO2 Surgical LaserOptomedic Medical Technologies, Ltd.GEXClass II
K950200IvidScott/Ross Designs, Inc.FPKClass II
K950187Futura OneDegussa AGEJTClass II
K950065Conmed Veni-Gard(tm i.v. Dressing-Product Line Extension and ModificationsConmedcorpMGPUnclassified
K946386Candela Ruby Laze Q-Switched Ruby LaserCandela CorporationGEXClass II
K946377Electroprobe Single Use Electrosurgical ProbesXimed Medical SystemsGEIClass II
K946078Hospital Broad Band Cleandr - Disinfectant-DeodorantClariant CorporationLRJClass I
K945005Panoplex Hydrogel Wound DressingSage Pharmaceuticals, Inc.MGQUnclassified
K944936Mitek G III Anchor, Mitek Ls AnchorMitek Surgical Products, Inc.JDRClass II
K944768Olympus Inorganic Phosphorus ReagentOLYMPUS Corporation of the AmericasCEOClass I
K944115Heparin Assay Cartridges and ControlsMedtronic Hemotec, Inc.GFTClass II
K943842Pulse Oximeter Model 305Palco Laboratories, Inc.DQAClass II
K943720Iti Transversal Screwing SystemStraumann USA, LLCDZEClass II
K943153Microsample Coagulation AnalyzerBio/Data Corp.GKPClass II
K942796Presssion S IIIChattanooga Group, Inc.JOWClass II
K942648In Vitro Diagnostic Urine Reagent Strips SetTeco DiagnosticsJILClass II
K942622Laseaway Q-Switched Nd:yag Laser SystemMdi, Inc.GEXClass II
K942455Lifescan Surestep Blood Glucose Monitoring SystemLifescan, Inc.CGAClass II
K942097Toa Medical Electronics Ca-5000Sysmex CorporationJPAClass II
K942096Toa Medical Electronics Ca-1000Sysmex CorporationJPAClass II
K940028Endoscope SheathXomed-Treace, Inc.EOBClass II
K935982Special Electromagnetic Therapeutic ApparatusC.M.D. Acupuncture CenterILYClass II
K935192Emit Iic CalibratorsSyva Co.DKBClass II
K950991Dyract II RestorativeDentsply Intl.EBFClass II
K950951Neocast C, V, SNeodontics IncEJHClass II
K950860PermaluteUltradent Products Inc.KLEClass II
K950859PermasealUltradent Products Inc.EBFClass II
K950690Prosys Urihesice System NlConvatec, A Division of E.R. Squibb & SonsEXJClass I
K950517Harmony Line PfIvoclar North America, Inc.EJTClass II
K950291Digital 625HfFischer Imaging Corp.IZOClass I