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 2203 of 3531
510(k) clearances, page 2203 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K941695SunglassesSun Creations, Inc.HQYClass I
K941357Vinyl Examination Glove, Powder FreeCanopus Medical Supply Co., Ltd.LYZClass I
K941297Yung Hsu Optical Works CoYung Hsu Optical Works Co.HQYClass I
K941276Brimfield Precision Second Generation Grasper/dissectorSpringfield Surgical InstrumentsGCJClass II
K941138Sg-22 SunglassesAmerican Bestin Mfg., Inc.HQYClass I
K941097Aurium D16Argen Precious Metals, Inc.EJTClass II
K941077SunglassesKingsun Optical Ent. Co., Ltd.HQYClass I
K941072Aurium Pc16Argen Precious Metals, Inc.EJTClass II
K941067Aurolite CbArgen Precious Metals, Inc.EJTClass II
K941056Latex Examination Gloves, Powder FreePt. Eka Wira AsiaLYYClass I
K940990SunglassesJpreynolds Co., Inc.HQYClass I
K940977Spectacle FramesSuper Optical, Inc.HQZClass I
K940871Umbili-Cath-PGesco Intl., Inc.FOSClass II
K940675SybraloySybron Dental Specialties, Inc.EJJClass II
K940599Dual Air/water Filter Cartridge Handle KitQ. C. Filter, Inc.EIAClass I
K940551Endoscopic Surgical InstrumentsTnco, Inc.GCJClass II
K940546Granitec Ionomer Resin CementConfi-Dental Products Co.EMAClass II
K940459Multipurpose Resin Cement with Fluoride (Mrcf)Dentsply Intl.EMAClass II
K940431Tecnadyne 20/20 Fog Inhibitor KitTecnadyne Scientific, Inc.GCJClass II
K940285Acuson Picture Archiving & Communication System ModificationAcuson Corp.IYNClass II
K940223Learn Mode Waterproof Pendant Panic ButtonInteractive Technologies, Inc.IQAClass II
K936116Kodak Ektascan Network Interface/for Other ManufacturersEastman Kodak CompanyLMDClass I
K936103Crown SunglassesCapo, Inc.HQYClass I
K935037Non-Prescription SunglassesXiamen Chenyi Plastics Industrial Co., Ltd.HQYClass I
K934765Trilogy Acetabular SystemZimmer GmbHLPHClass II
K934706Candela Pltl-1 Laser System: Pigmented Lesion Laser and TatulazrCandela CorporationGEXClass II
K934344Home Amb-AlertMedwayKMIClass I
K934253Exactech All Poly Acetabular CupExactech, Inc.JDZClass I
K933171Inman Irrigation Tapered ProbeInman Medical Corp.KYZClass I
K932133EysotekIsotech Corp.FXXClass II
K932132EysotekIsotech Corp.FXXClass II
K931642Rmhs Monolithic Femoral ComponentSmith & Nephew Richards, Inc.LPHClass II
K931429Cool CutMitabHWEClass I
K930891Synthes (USA) Univ Spine Rod/sacral Screw Fix SystSynthes (USA) Products LLCKWPClass II
K930347Shaids Protective GlassesDepuy, Inc.HOYClass I
K925816Sharps Containment SystemPost Medical, Inc.FMIClass II
K924830Luxatemp AutomixDMG Chemisch Pharmazeutische Fabrik GmbHEBGClass II
K921219Philips Dci-SxPhilips North America LLCOWBClass II
K941158Flexible Biopsy Cup ForcepsSurgical Technologies, Inc.EOQClass II
K941071Aurolite Cb25Argen Precious Metals, Inc.EJTClass II
K941070Aurolite Cb+2Argen Precious Metals, Inc.EJTClass II
K941069Aurolite Mt1Argen Precious Metals, Inc.EJTClass II
K941068Aurolite Cb80Argen Precious Metals, Inc.EJTClass II
K940701Bennett Mammography Positioning Chair Model No. M-PchBennett X-Ray Corp.IZHClass II
K940685Pretreatment SolutionDentsply Intl.ELWClass II
K940414Iodoflex PasteOclassen Pharmaceuticals, Inc.KMFClass I
K940227Scpu X-Ray GeneratorGeneral Electric Co.IZOClass I
K935856Dentaurum Space MaintainerDentauraum, Inc.DYTClass I
K935822Phase I CurettePhase I Corp.HCYClass I
K935461Vector Ambulatory Drug Delivery SystemInfusion Technology Intl.FIHClass II