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 2373 of 3531
510(k) clearances, page 2373 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K921128Endotracheal Tube StyletEastmed Enterprises, Inc.BSRClass I
K920501Silclamps Degania SiliconePuritas Health Care, Inc.DXCClass II
K920264Bio-Detek Tracerite EEG ElectrodeZOLL Medical CorporationGXYClass II
K915826Bio-Polar ForcepsApplied MedicalGEIClass II
K914998Microaire(r) Facial Bone Plating SystemMicro Surgical Instruments Corp.HRSClass II
K914300Phoenix 5 Urodynamics SystemAspen Medical, Ltd.FAPClass II
K910077Crit-ScanNoninvasive Medical Technology Corp.DQAClass II
K913813Jiffi Condom (Rubber) ContraceptiveSime Health, Ltd.HISClass II
K920997Cd-ChexStreck Laboratories, Inc.GGLClass II
K920996Barrier Surgical Gown with Symetry FabricJohnson & Johnson MEDICAL GmbHFYAClass II
K920995Barrier Drape Sheet with Symetry FabricJohnson & Johnson MEDICAL GmbHKKXClass II
K922178Companion 318 Nasal CPAP System -- ModificationMedtronic, Inc.BYEClass II
K921349Sterile,disposable Eye DressingDeRoyal Industries, Inc.HMPClass I
K921227Tencel Topical Wound Dressing/surgical SpongeCourtaulds Fibers, Inc.NABClass I
K921099Syntron Quikstrip/e.z. Strip Pregnancy Home TestSyntron Bioresearch, Inc.LCXClass II
K921036Sonos 100 Ultrasound Imaging SystemHewlett-Packard Co.ITXClass II
K921009Kaltostat Fortex Wound DressingCalgon Vestal Div.KMFClass I
K920944Fts-200 Gas SystemTrek Medical Products, Inc.BSZClass II
K920847Ethicon Ligaclip Endo Ld Applier/dividerEthicon, IncFZPClass II
K920731X-Ray Tube Assembly Circlex1.2ugShimadzu Medical SystemsITYClass I
K920726Urological X-Ray Table Hs-10AShimadzu Medical SystemsIXRClass II
K920644F499 Deluxe Electric Tooth Brush W/ StandFairform Mfg., Co., LtdJEQClass I
K920538Protective Radiografic GloveBurkhart Roentgen Intl., Inc.IWPClass I
K920431Omnitron Needle Applicators 18 and 21 GaugeOmnitron Intl., Inc.JAQClass II
K920282Pre-Cut Tracheostomy Dressing Sterile, DisposableTrinity Laboratories, Inc.NABClass I
K915821Multiple Sterile Gauze Bandage Rolls, Vari SizesKerma Medical Products, Inc.NABClass I
K915695Procel Burn CoverW. L. Gore & Associates, Inc.MGPUnclassified
K915526Coated Surgipro(tm) Polypropylene Surgical MeshUnited States Surgical, A Division of Tyco HealthcFTLClass II
K915161Augustine Fiberoptic LaryngoscopeAugustine Medical, Inc.CCWClass I
K910449PrestitchCrantec Co.KCYClass I
K922004Modification Puritan-Bennett Infant Pm2Medtronic, Inc.BTMClass II
K921778Directdraw SuperserumAccriva Diagnostics, Inc.GIMClass II
K921575Igg Suclass EiaVirotech DiagnostikaDEWClass II
K921516P2900 X-Ray GeneratorPrecise Optics Photo Medic Equipment, Inc.IZOClass I
K921432Shimadzu Whole Body X-Ray CT Scanner Sct-4500TfShimadzu Medical SystemsJAKClass II
K921428Captus 500Capintec Instruments, Inc.IZDClass I
K921296Adac S315Philips North America LLCIYXClass I
K9212859105 Rigid Telescopic EndoscopeKay Elemetrics Corp.EQLClass I
K921184Rls 9100 Rhino-Laryngeal StroboscopeKay Elemetrics Corp.EQLClass I
K921046Bo Power SupplyResonex, Inc.LNHClass II
K920925Comfeel Contour DressingMEDLINE INDUSTRIES, LP - NorthfieldKMFClass I
K920728X-Ray Diagnostic Table Ysf-100Shimadzu Medical SystemsIXRClass II
K920540Radiological Protective Eye ShieldBurkhart Roentgen Intl., Inc.IWSClass I
K920200Ultra-Vision Detail Intensifying ScreenE.I. Dupont de Nemours & Co., Inc.EAMClass I
K920190Ultra-Vision Rapid Intensifying ScreenE.I. Dupont de Nemours & Co., Inc.EAMClass I
K920132Syn Elisa Beta 2 Microglobulin Test KitElias U.S.A., Inc.JZGClass II
K915617Lsf Ha Coated Femoral HipImplant Technology, Inc.MEHClass II
K915359Promeon Hydrogel Dressing #45 Sterile W/ MeshMedtronic, Inc.NAEClass I
K915357Promeon Hydrogel Dressing #45 Sterile W/o MeshMedtronic, Inc.NAEClass I
K914926Scandiplan - Version 338Scanditronix, Inc.KPQClass II