510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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
45,902 of the 176,299 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
20262,502
176,299 records, page 3450 of 3526
510(k) clearances, page 3450 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K780516Gentamicin Ria KitAntibodies, Inc.DJBClass II
K780492Gamma Stik 125I T3 Uptake KitAlpha Gamma LaboratoryCDPClass II
K780486Stiksep-T3 KitNuclear Diagnostics, Inc.CEEClass II
K780483Fiber Optic HandpieceSyntex Corp.EFBClass I
K780425Biophysical Monitoring SystemGould, Inc.DXJClass II
K780373Stac SystemTechnicon Instruments Corp.CKAClass I
K780367Ria Sys. for Human Luteinizing HormoneCalbiochem-Behring Corp.CEPClass I
K780358Acces. Analog Output Adaptor Model 910Applied Medical ResearchDXNClass II
K780137Clamp, Incontinence, BaumruckerGreenwald Surgical Co., Inc.FHAClass I
K772116Aminoglycoside Test SystemNichols Institute DiagnosticsDJBClass II
K780666Daystar Selectra & Selectra/orbiterCastle Co.FSYClass II
K780643Shadow-CathsQuinton, Inc.FJSClass II
K780580Temperature IndicatorRespiratory Care, Inc.KPDClass II
K780562Aquapak Prefilled HumidifierRespiratory Care, Inc.BTTClass II
K780535Humidifier FilterHudson Oxygen Therapy Sales Co.CAHClass II
K780470H.p. Medical Grade Silicone TubingDow Corning Corp. Healthcare Industries MaterialsKDLClass II
K780426Body WarmerQ-Matic Corp.IMDClass I
K780409Coloplast-Duraseal Ostomy ApplianceC.R. Bard IncEZSClass I
K780299Total Knee SystemRichard'S Medical Equip., Inc.HRYClass II
K780556Spect Rim (Liss)BD Becton Dickinson Vacutainer Systems PreanalyticKSGClass II
K780544Disc-Pak RotatorTechhnilab Instruments, Inc.GLEClass I
K780475Dac-Cel Digoxin Radioimmunoassay KitBurroughs Wellcome Co.DONClass II
K780467Emit Antiepileptic Drug CalibratorsSyva Co.JISClass II
K780466Emit Carbamazepine AssaySyva Co.KLTClass II
K780443Sgot/ast Reagent SystemAmerican Monitor Corp.CITClass II
K780413Low Iionic Strength SolutionPfizer IncKSGClass II
K780401Thyro-Zyme-T4 Assay KitCoulter Electronics, Inc.CDXClass II
K780351Normal Unassayed Control SeraMacomb Chemical Co.JJYClass I
K780097Quality Control System, SpectraBD Becton Dickinson Vacutainer Systems PreanalyticKSFClass II
K780641Dental Rotary Carbide Burs 76EjlTeledyne DenscoEJLClass I
K780603Cold PackAbco Dealers, Inc.IMDClass I
K780566Health Seat SystemG & W Applied Science LaboratoriesDXNClass II
K780560Dental AmalgamatorL.D. Caulk Co.EFDClass I
K780540Electric Response AudiometerLife-Tech Instruments, Inc.GWJClass II
K780532Percutaneous Sheath Introducer KitArrow Intl., Inc.DYBClass II
K780511Snap-FitE. R. Squibb & Sons, Inc.EXBClass I
K780454Active-LifeE. R. Squibb & Sons, Inc.EXBClass I
K780416Pantridge Mk III Defibrillator/monitorIpco Corp.LDDClass II
K780302Blood Flowmeter SystemMedtronic, Inc.DPWClass II
K780175Rate Programmer Model 520Intermedics, Inc.KRGClass III
K770534Therapeutic Apparatus, Dierker TypeWell Being Ent.KDHClass II
K780616Hydron Burn Disposable Dispenser SetAbbott MedicalKMFClass I
K780612Stockinette, SterileAbco Dealers, Inc.ILGClass I
K780606BandageAbco Dealers, Inc.FQMClass I
K780604Shave PrepAbco Dealers, Inc.KXFClass I
K780602Syringe (Irrigation)Abco Dealers, Inc.FMFClass II
K780600Irrigation TrayAbco Dealers, Inc.FMFClass II
K780599Syringe, Ear & UlcerAbco Dealers, Inc.KCPClass I
K780596StopcockAbco Dealers, Inc.FMGClass II
K780595Mini-Irrigation TrayAbco Dealers, Inc.FMFClass II