510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
45,969 of the 176,366 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
20262,569
176,366 records, page 3256 of 3528
510(k) clearances, page 3256 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K813277Boundary Drape TapeThe Buckeye Cellulose Corp.KKXClass II
K813197Oxygen Connecting TubeNorthern Medical IndustriesBYXClass I
K813078Contura Dispos. Surg. Face MaskAmerican Convertors Div., American PharmasealFXXClass II
K813063Flat DrainSil-Med Corp.GBWClass I
K813322Ortho* Unassayed Control Serum Level IIIOrtho Diagnostic Systems, Inc.JJYClass I
K813321Ortho* Unassayed Control Serum Level IOrtho Diagnostic Systems, Inc.JJYClass I
K813318Mini-ShakerDynatech Corp.JRQClass I
K813310No-Hoil Combostat II KitRia Products, Inc.CDDClass II
K813309Ra-80 Positive ControlSun-KitDHRClass II
K813295Ortho CO2 Diluent Level IIIOrtho Diagnostic Systems, Inc.JJYClass I
K813294Ortho CO2 Diluent Level IIOrtho Diagnostic Systems, Inc.JJYClass I
K813293Ortho CO2 Diluent Level IOrtho Diagnostic Systems, Inc.JJYClass I
K813288Neia Transferrin EnzymeimmunoassayNew England Immunology Assoc.DDGClass II
K813272A-1 in-Home Pregnancy TestC.F. Medical, Inc.LCXClass II
K813261Riagen Pap RiaBiogenex Laboratories, Inc.JFHClass II
K813219Caraflex Elastic Polymer Plaster BandaCarapace, Inc.ITGClass I
K813216Secure Fdi Test KitBeckman Instruments, Inc.JHGClass II
K813087Aburia-Ck Ria Test KitIntl. Immunoassay Laboratories, Inc.JHXClass II
K813086Andria-Fsh Ria Test KitIntl. Immunoassay Laboratories, Inc.CGJClass I
K813031Ms-2 Bacterial Identification SysAbbott MedicalJTOClass I
K812994Minocycline 30Mcg Antimicrobial Sus. DskGeneral DiagnosticsJTNClass II
K812950Qac ControlThe Quality Assurance Service Corp.DIFClass I
K812866Astra Reagent Concentrate SystemNobel Scientific Industries, Inc.CGAClass II
K812789Acu-Slide TestC.F. Medical, Inc.JHJClass II
K812788A-1 TestC.F. Medical, Inc.JHJClass II
K812766Pcs-5 AccessoriesTimeter Instrument Corp.BTIClass II
K812298Fibrogen(fibrin Split Product) AntigenSyn-Kit, Inc.GHHClass II
K813332Bristol Ballon Introducer, Mandril SetInmed Corp.NWUClass II
K813319Aspirator Venturi System Model 55-JvJ. H. Emerson Co.GCXClass II
K813287Cc-201 ECG Monitoring SystemsAnthro-Metrics Corp.DSIClass II
K813282Synevac Vacuum Curettage SystemsSynemed, Inc.HHIClass II
K813279Electrocardiograph Cm3000Philips North America LLCDPSClass II
K813270Fecal Incontinence CollatorHollister, Inc.EXBClass I
K813267Disposable Diaphragm DomesDio-Med Corp.DRSClass II
K813252Unscented Menstrual Pads-Mini PadsI.C.D. Industries, Inc.HHDClass I
K813251Unscented Menstrual Pads-Maxi PadsI.C.D. Industries, Inc.HHDClass I
K813231TourniquetAspen Laboratories, Inc.KCYClass I
K813173Vrt Table W/integrating Tube Stand/elevGeneral Electric Co.KPRClass II
K813162Interad Whole Body CT ScannerInterad Systems, Inc.JAKClass II
K813156Ultra-Wide Safety Spectacle FrameZee Medical Products Co., Inc.HQZClass I
K813147Kodak Intensifying Screen 80-175Eastman Kodak CompanyEAMClass I
K813125Micro Transducer CathetersHoneywell, Inc.DREClass II
K813105Pressure Infusion PumpCalbio, Inc.KZDClass I
K813088Deseret Neolon Surgical GlovesWarner-Lambert Co.KGOClass I
K813062Vascular PawsSil-Med Corp.DXCClass II
K813037Flowguard Catheters & CannalaeAdvocacy International, Ltd.DWFClass II
K813029Valved Surgical AspiratorsImedixGCXClass II
K813021Fukuda Denshi...electrocardiograph Fd-36Brentwood Instruments, Inc.DPSClass II
K813020Bomed-NccomBomed Medical Mfr., Ltd.DXGClass II
K813009Teca Visual/audio Stimulator Model Cs-2Teca, Inc.GWJClass II