510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK 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
46,069 of the 176,466 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
20262,669
176,466 records, page 2780 of 3530
510(k) clearances, page 2780 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K873885Pharmacia Deltec Subcutaneous Infusion SetPharmacia Deltec, Inc.FPAClass II
K873858Amerlite Tt3 Assay, Lan.0003/1003/2003Amersham Corp.CDPClass II
K873833Thermocouple AdapterMallinckrodt Critical CareFLLClass II
K873735Medtronic Catheter Access Port Model 8500Medtronic, Inc.LJTClass II
K873728Deknatel Temporary Cardiac Pacing WireDeknatel, Inc.LDFClass II
K8737093 Ring Attachment for SyringesCondor MedicalFMFClass II
K873569Blood Needle HolderSage Products LLCFMIClass II
K872882Cannabinoid Enzyme Immunoassay KitGeneral DiagnosticsLDJClass II
K872764Ivac Nitroglycerin & Lipid Admin. Set Model S75053YFRNClass II
K872655Intelect 775Chattanooga Group, Inc.IPFClass II
K874234Surgical Prep Razor, Straight TypeDerma-Safe Co.LWKClass I
K874017Modified Retinal Camera Model Cr4-45NmCanon Medical Components U.S.A., Inc.HKIClass II
K873917Tonometer TapesRichmond Products, Inc.HKXClass II
K873912Richmond Visual Field ScreenerRichmond Products, Inc.HOOClass I
K873797Ti-Fit Total Hip SystemRichards Medical Co., Inc.LWJClass II
K873785Tecnol Fog-Free Surgical Mask W/derma-Touch TapeTecnol New Jersey Wound Care, Inc.FXXClass II
K873714Banana Knife, Disposable #Tm-1612Arthropedics, Inc.HTSClass I
K873713Triangular Knife, Disposable #Tm-1611Arthropedics, Inc.HTSClass I
K873711Retrograde Knife, Disposable #Tm-1613Arthropedics, Inc.HTSClass I
K873710Magnetic Retriever, 1.7Mm W/luer Fitting Tm-1350Arthropedics, Inc.HWBClass I
K873652Hook Probe #Tm-1376Arthropedics, Inc.HXBClass I
K873651Blunt Measuring Probe W/2mm Gradations #Tm-1375Arthropedics, Inc.HXBClass I
K873650C-O-T Set (Cannula, Obturator and Trocar) #Tm-1360Arthropedics, Inc.HRXClass II
K873580Mhti CT-Sim Radiation Therapy Treatment SimulatorMedical High Technology International, Inc.KPQClass II
K873578Lee Allen's Universal Motility ImplantOculo-Plastik Reg'DHPZClass II
K873525Deknatel Trocar CatheterDeknatel, Inc.JOLClass II
K873517Deknatel Thoracic CatheterDeknatel, Inc.JOLClass II
K873513Serrated Grasping Forceps, Curved UpArthropedics, Inc.HTDClass I
K873512Serrated Grasping Forceps, RightArthropedics, Inc.HTDClass I
K873511Serrated Grasping Forceps, LeftArthropedics, Inc.HTDClass I
K873510Serrated Grasping Forceps, Curved DownArthropedics, Inc.HTDClass I
K873506Cup Biopsy Forceps, Curved UpArthropedics, Inc.HTDClass I
K873505Cup Biopsy Forceps, Curved DownArthropedics, Inc.HTDClass I
K873504Cup Biopsy Forceps, RightArthropedics, Inc.HTDClass I
K873503Cup Biopsy Forceps, LeftArthropedics, Inc.HTDClass I
K873502Scissor, RightArthropedics, Inc.HRRClass I
K873501Scissor, LeftArthropedics, Inc.HRRClass I
K873444Entech Enteral Pump and SetEntech, Inc.FRNClass II
K873422Obf Model 115 Computer Tonometer SystemOcular Blood Flow Laboratories, Inc.HKXClass II
K873419Video Printer SystemTechnology for Imaging, Inc.KQMClass I
K873314Toshiba, Smit RoentgenInland Tube Corp.ITYClass I
K873122Tks 4000 Auto PerimeterVismed, Inc.HPTClass I
K872533The CartArthropedics, Inc.HRXClass II
K872281Raylor Fusion FunnelCedar Surgical, Inc.HXRClass I
K872005Maximum, Latex Prophylactic BrandSafe Product SuppliesHISClass II
K873982Gx-Mobile X-Ray UnitGendex Corp.IZLClass II
K873956UltimeterRadiation Measurements, Inc.LHOClass I
K873900Portable Ventilator Patient CircuitMedtronic, Inc.BZOClass I
K873587Blood Analysis GasNational WeldersBXKClass I
K873447Disposable Condensate Bottle for 7200 VentilatorDhd Medical Products Div. Diemolding Corp.BYHClass I