510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK 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
46,069 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 2653 of 3530
510(k) clearances, page 2653 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K890401Golden Mean Machine(tm) (Class 2)Bennett Ergonomic Labs, Inc.ISDClass II
K890134Ftk Fecal Transport KitEvergreen Scientific, Inc.LIOClass I
K890126Kamed StethoscopeD.R.G.LDEClass I
K884841Retractable Piston Syringe W/luer-Lock CollarHall Medical LaboratoriesFMFClass II
K884797Berichrom Alpha-2-AntiplasminBehring Diagnostics, Inc.GGPClass II
K884354Imager Flush CathetersMedi-Tech, Inc.DQOClass II
K883948Modified Numed Balloon Angiographic CatheterNumed IncDYGClass II
K882610Cook-Gianturco Biliary Z StentCook Inc.FGEClass II
K892118Non-Sterile Masks and CapsParamount Products, Inc.FYAClass II
K891677Coated Isolation GownDurante Intl., Inc.FYCClass II
K891621Sterile Surgeons' GlovesAlbors-Menconi Latex Corp.KGOClass I
K891293Sls Simulator (Models Sls-9 and Sls-14)Philips North America LLCKPQClass II
K890795Respironics Sealeasy IIRespironics, Inc.BSJClass I
K890606Ohmeda 5330 Agent MonitorGE HealthcareCBQClass II
K890459James River Biogel Powderless Surgical GlovesJames River Corp.KGOClass I
K890330Medilog 6000-Fd Report GeneratorOxford Medilog, Inc.DSIClass II
K884633Arista and Orient Surgical GlovesDurante Intl., Inc.KGOClass I
K884598Shimadzu Digital Subtraction System Dar-1200Shimadzu Precision Instruments, Inc.JAAClass II
K884231Surgical 'Laser' DrapeHenley Intl.KKXClass II
K883782Belzer Uw-CssDu Pont Critical CareKDLClass II
K891983Cam-Wrap(tm) New Sterilization ProcedureMedical Dynamics, Inc.KCTClass II
K891759Kinetic Model 330Kinetic Biomedical Services, Inc.FSSClass II
K891758Kinetic Model 132Kinetic Biomedical Services, Inc.FSSClass II
K891757Kinetic Model 1000Kinetic Biomedical Services, Inc.FSYClass II
K891756Kinetic Model 500Kinetic Biomedical Services, Inc.FSYClass II
K891597Nosey Shades (Sunglasses) NonprescriptionCreative Images, Inc.HQYClass I
K891104Cd Telemetry SystemsMarquette Electronics, Inc.DRGClass II
K890841Titanium StaplesEthicon, IncGDWClass II
K890735Coated Apex ProbeAnalytic TechnologyLQYUnclassified
K890725Photochromic LensPpg Industries, Inc.HQYClass I
K890580Lipid StopcockNorth American Instrument Corp.DTLClass II
K890425Neotech Mucus Trap W/catheterNeotech Products, LLCBSYClass I
K890338Medilog EditorOxford Medilog, Inc.DSIClass II
K890285Prosthetic Cement RemoverAlbert K. ChinLZVClass II
K890282Resubmitted Abbott Lifecare Model 3 Hb PumpAbbott MedicalFRNClass II
K885204Horizon 2000 Arrhythmia Monitor Option - (Alarms)Mennen Medical, Inc.DSIClass II
K885201Ossicular Prostheses 4 Partial, 4 Total, 2 ConvertMicrobio-Medics, Inc.ETAClass II
K885054System Seventy SevenScinticor, Inc.IYXClass I
K885036Porous Coated Genesis Femoral ComponentRichards Medical Co., Inc.JWHClass II
K884938Vital Signs MonitorTico Medical Instruments, Inc.DSKClass II
K884697Heparin Bonding for CathetersDaig Corp.DTBClass III
K884327Excel Y-Connector Cat. #E-201Medical Profiles, Inc.LITClass II
K883969Uni-Knee Component of the Natural-Knee SystemIntermedics OrthopedicsHRYClass II
K8915893Mm Disposable SpeculaSemantodontics, Inc.FXGClass I
K891537Core Biopsy Needle, Catalog Code #54006Dlp, Inc.GDMClass I
K891385Vitek Immunodiagnostic Assay System (Vidas)Vitek Systems, Inc.DEWClass II
K891155Iron ReagentMedical Analysis Systems, Inc.CFMClass I
K891141Carerite Face MaskCost Rite Health Products, Inc.FXXClass II
K890976Patient Examination GloveCranberry (M) Sdn. Bhd.LYYClass I
K890773Hi Chem Inorganic Phosphorus Reagent Kit #88196Hichem DiagnosticsCEOClass I