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 3181 of 3528
510(k) clearances, page 3181 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K823743Model 40-80-2 Dispos. Esophageal StethoYBZTClass II
K823517The Kline ApplicatorKline Technologies, Ltd.HGDClass I
K823486Touch-N-Heat Model 5001Analytic TechnologyEKMClass I
K823478Scented Menstrual PadsProcter & Gamble Mfg. Co.HHLClass II
K823477Unscented Menstrual PadsProcter & Gamble Mfg. Co.HHDClass I
K823461Axipump Manual Breast PumpD.J. Colgate Medical, Ltd.HGYClass I
K823428Kelly Inflatable T DrainAkron Catheter, Inc.FGEClass II
K823262Model Sp5800 #8 French Intro. KitGould, Inc.DYBClass II
K822817Doce All-in-the-Ear AidFidelty Hearing Instruments, Inc.FSDClass I
K830014Hema - Nv Trans. Blood Filter 100/800Abbott MedicalCAKClass II
K830011Vfs 1000/Screening Function AnalyzerCooperVision, Inc.HOXClass I
K828676Dermalight SpotDr. K. Honle GmbH
K828675Dermalight Uvastar 400Dr. K. Honle GmbH
K828674Dermalight Blue-PointDr. K. Honle GmbH
K828670Uvatec Suntamed 400Solitec GmbH
K828661Barium EnemasThe Healthcare Group, Inc.
K823901Trephine Blades-Various ModelsEdward Weck, Inc.HRGClass I
K823882M-BraceBuckman ConsultantsIPYClass I
K823881Arteriovenous Blood Tubing Set forAmicon, Inc.KDIClass II
K823835Spembly 140 Cryosystem Probes & TipsKeller Instruments, Inc.HQAClass II
K823779DialyteRenal Dynamics, Inc.KPOClass II
K823774Wilson Eustachian Tubal, SonographAntares Technical Associates, Inc.ETKClass I
K823419Hc 1M Metalbacked Acetabular CupOsteonics Corp.JDIClass II
K823244Tech. Claratron & Industrial AmplifierLongview Hearing Aid CenterESDClass I
K823086Deseret Surgeon's Glove AccessoryParke-Davis Co.KGOClass I
K830026Fiberscope Disinfectant IrrigatorKeymed, Inc.FEBClass II
K830021A.v. Fistula Cannulation SetsTravenol Laboratories, S.A.KOCClass II
K828669Computed Cinetomography Scanner, Model C-100Imatron, Inc.
K828621Video Image ProcessorPie Data, Inc.
K828583Lasermed Oculase Argon LaserLasermed Corp.
K823903Rubber Inflatable RingDuro-Med Ind., Inc.KICClass I
K823877Berkeley HarnessBerkeley Electric Wheelchair Co.KNNClass I
K823876Berkeley ForkBerkeley Electric Wheelchair Co.KNNClass I
K823875Chain KitBerkeley Electric Wheelchair Co.KNNClass I
K823874Berkeley BrakeBerkeley Electric Wheelchair Co.KNNClass I
K823873Chain SilencerBerkeley Electric Wheelchair Co.KNNClass I
K823865Advance Sys. Emit-Cad Lidocaine ControlSyva Co.LAXClass I
K823856Medcare General Purpose TrayMedcare ProductsFSMClass I
K823855Medcare Incision & Drainage TrayMedcare ProductsFSMClass I
K823853Medcare Wound Closure TrayMedcare ProductsFSMClass I
K823823Lumbosacral SupportDanek Medical, Inc.IPYClass I
K823822Ankle WeightsDanek Medical, Inc.IODClass I
K823820Abduction PillowDanek Medical, Inc.IOZClass I
K823819Cast Toe CoverDanek Medical, Inc.LGFClass I
K823816Wheelchair Patient RestraintsDanek Medical, Inc.KNOClass I
K823814Hot/cold Pack HoldersDanek Medical, Inc.IMEClass I
K823813Traction AccessoriesDanek Medical, Inc.HSTClass I
K823812Various Supports and SplintsDanek Medical, Inc.IQIClass I
K823811Overhead Arm SlingsDanek Medical, Inc.ILEClass I
K823810A.c. SplintDanek Medical, Inc.ILIClass I