510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
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 3081 of 3528
510(k) clearances, page 3081 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K841267C-18Pentron Corp.EBFClass II
K841110NeurotracInterspec, Inc.GWKClass II
K841098Sheridan Ysi/sonatempSheridan Catheter Corp.BZTClass II
K841017Provider Infusion SetPancretec, Inc.FRNClass II
K840928Factor Deficient Substrate Plasma VIIIDiatech, Inc.GGPClass II
K840927Factor Deficient Substrate Plasma IIDiatech, Inc.GGPClass II
K840865Infant Star VentilatorInfrasonics Corp.CBKClass II
K840600Magne-DentMagne-DentEGGClass I
K840526AmethermEgnell, Inc.FMZClass II
K840396Electro-Mesh WrapWhiting & Davis Co.GXYClass II
K840395Electro-Mesh GloveWhiting & Davis Co.GXYClass II
K840384Diagnostic Dilatation & Menstrual KitIntl. Medical Technologies, Inc.HHIClass II
K840383Menstrual Aspiration KitIntl. Medical Technologies, Inc.HHIClass II
K840382Vacuum Aspiration CatheterIntl. Medical Technologies, Inc.HHIClass II
K840381Tapered Cervical DilatorIntl. Medical Technologies, Inc.HHIClass II
K840380Uterine SoundIntl. Medical Technologies, Inc.HHMClass I
K840195Facs AnalyzerBD Becton Dickinson Vacutainer Systems PreanalyticGKZClass II
K834567Q3000Quinton, Inc.DQKClass II
K834473Multi-Lumen Central Venous Cath. KitBurron Medical Products, Inc.LJSClass II
K834430Omni Infant Phototherapy UnitRocky Mountain Medical Corp.LBIClass II
K832401RespirometerKinetixBZGClass II
K831803PulmometerKinetics Measurement Corp.BZGClass II
K841217Picker Myelogram Tray-Pms MyelogramProfessional Medical SystemsFMIClass II
K834135Sterile Suture BootsDevon Industries, Inc.KDDClass I
K832699Hydron Wound Dressing Fast Seat KitNational Patent Development Corp.FROUnclassified
K833024OftalmografUniversal Instruments Corp.
K841718Frekatheter Venous Catheterisation SysFresenius USA, Inc.
K841505Surgi-Med Table Model 485-LtMidmark Corp
K841480Infection Control ValveSuperior Plastic Products Corp.BSYClass I
K841479Bio Spec Strep-a-Fluor Test KitBio Spec, Inc.JTOClass I
K841454RF Test KitDifco Laboratories, Inc.DHRClass II
K841364Coagulation Factor V Deficient SubstrAmerican DadeGGPClass II
K841298Hole Chamfering DeviceTechmedica, Inc.GFFClass I
K841297Techmedica Drill GuideTechmedica, Inc.FZXClass I
K841255Boundary Single-Use GownsProcter & Gamble Mfg. Co.
K841199Fiberglass Mouth MirrorsHenry Schein, Inc.EAXClass I
K841175William Harvey H-4720 Non-Filtered CarC.R. Bard IncDTNClass II
K841171Trilicon Brease Prosthesis DifferentBaurs Krey Assoc., Inc.GBIClass I
K841127Virgo Reagents Indirect FluorscentElectro-Nucleonics Laboratories, Inc.DHNClass II
K841122Tracheostomy Care TrayMedcare ProductsFSMClass I
K841037Penrose DrainsInmed Corp.
K840980Half Round FileMed-Tool, Inc.HTCClass I
K840979Slip Joint PlierMed-Tool, Inc.HTCClass I
K840978Toggle Locking PlierMed-Tool, Inc.HTCClass I
K840931Sun BedsWakewood SunbedsFTCClass II
K840901Phase II Free T4 KitMedical & Scientific Designs, Inc.CECClass II
K840873Crystar Porcelain Margin Powder/liquidShofu Dental Corp.EIHClass II
K840856Modular Construct Frame External FixaPrecision Medical Devices, LLCJECClass II
K840820Securline Surgical Skin Marker 1000Precision Dynamics CorporationFZZClass I
K840817Disposable, Hyperbaric Oxygen ChamberHospitak, Inc.KPJClass II