510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK 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
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 2341 of 3531
510(k) clearances, page 2341 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K924573Systemate Plus Triglyceride-Glycerol Blanked TestEm Diagnostic Systems, Inc.CDTClass I
K924471Kodak Ektachem Clinical Chemistry Slides (Nail)Eastman Kodak CompanyJGSClass II
K924025Oto-Brite HandleJEDMED Instrument CompanyERAClass I
K924019Deluxe Electric Combination Tilt TableMidland Mfg. Co.INQClass I
K924009Intravascular Guide Wire and Extension WirePilot Cardiovascular Systems, Inc., Sub. C.R. BardDQXClass II
K923948Sat PadAlliance Pharmaceutical Corp.LNHClass II
K923914If-II (Tm), Model 7200Medical Devices Inc.IPFClass II
K923819Eec-1 PackageMed Labs, Inc.ILQClass II
K923797Model 25 Therapeutic Ultrasound -- ModifiedRich-Mar Corp.IMGClass II
K923776Benderev Drill GuideNeimark Labs, Inc.HXYClass I
K923195Myoglobin Elisa Test KitImmuno Diagnostic Center, Inc.DDRClass II
K923173Obalon CoverTurnsoft, Inc.FMWClass I
K922434A Port Implantable Vascular Access System Line ExtTherex Corp.LJTClass II
K922087Anterior Cervical Plate SystemSofamor Danek Mfg., Inc.KWQClass II
K922041Primary Surgical Dressing TrayTransidyne General Corp.FMFClass II
K921928Soft-CoverAdroit Medical Systems, Inc.FMWClass I
K921836Perfecta Total Hip System, Ceramic Femoral HeadOrthomet, Inc.LZOClass II
K921717Bicore Smartvalve Occlusion ValveBicore Monitoring SystemsBZKClass II
K921379A-Port Implantable Vascular Access System Line ExtTherex Corp.LJTClass II
K921336Trocar Grasper/anvil ApproximatorEndoscopic Surgical Products, Inc.GCJClass II
K920791Gyroscan S15/acs-IIPhilips North America LLCLNHClass II
K920578Philips Gyroscan T5 Series IIPhilips North America LLCLNHClass II
K920166Modular Design Electrosurgical Laparoscopy IntrConmedcorpGEIClass II
K915317Putman StabilizerJ. Michael Putman, M.D., P.A.GCJClass II
K914765Siemens Np Noninvasive Blood Press Measurement SysSiemens Medical ElectronicsDXNClass II
K912328Electronic Muscle Stimulators, Excel II, ModifiedAdvanced Rehabilitative Technology, Inc.IPFClass II
K924232Spectacle FramesAptaker Co., Inc.HQZClass I
K924033Altex Model Ust-3000EOptro-Mechanics (USA) Corp.HQCClass II
K923881Quadrature Cervical Contour CoilMagnetic Research, Inc.LNHClass II
K923821Document Chem V Calibration Verification Test SetCasco StandardsJJXClass I
K923795Document Chem I Calibration Verification Test SetCasco StandardsJJYClass I
K923794Document Chem II Calibration Verification Test SetCasco StandardsJJXClass I
K923793Document Chem III Calibration Verification TestCasco StandardsJJXClass I
K923675Denspro Medium Mint Prophy PasteTeledyne GetzEJRClass I
K923674Denspro Coarse Mint Prophy PasteTeledyne GetzEJRClass I
K923567Medtronic Model 3888 Pisces-Quad Plus LeadMedtronic, Inc.GZBClass II
K922960Various Cameo Med Amniocentesis Trays, DisposableCameo, Inc.HIOClass I
K922803Wellwash 4 Mark IIDenley Instruments, Inc.JQWClass I
K922746St 20 Portable AudiometerMaico Hearing Instruments, Inc.EWOClass II
K921927Nicolet VoyageurNicolet Instrument Corp.GWQClass II
K921615Lensonic(tm) Contact Lens Care AccessoryPersonal Professional Products, Inc.LYLClass II
K920708Multilase 2500 aTeknomed, Inc.GEXClass II
K915731Electrosurgical Units Esu 30, 70, 70 B, 70 DigitalElmed, Inc.GEIClass II
K913982Lifeshield Anesthesia SetAbbott MedicalFPAClass II
K913917Multilase 2100 C, 2100 DTeknomed, Inc.GEXClass II
K913436Pxi Pneumatic Compression PaddleBrotherston/PxiIZGClass II
K913435Pxi UrcdBrotherston/PxiKPRClass II
K924914Phonak Pico-Forte Ppc-P-2 Bte Hearing InstrumentPhonak, Inc.ESDClass I
K924913Phonak Pico-Forte Ppc-L-P-2 Bte Hearing InstrPhonak, Inc.ESDClass I
K924911Phonak Pico-Forte Pp-Sc-2 Bte Hearing InstrumentPhonak, Inc.ESDClass I