510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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
46,018 of the 176,415 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
20262,618
176,415 records, page 2977 of 3529
510(k) clearances, page 2977 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K852016Laser Plateletcal/multipleR & D Systems, Inc.KRYClass II
K851915Curing LightTechnology, Inc.EBZClass II
K851814Wheelchair CushionsDignicareKICClass I
K85178627-230 to 27-234 Various Cast Breakers, WolfArtiberiaLGGClass I
K851672Nyhus/nelson TubeBissell Medical Products, Inc.KNTClass II
K851630Tmx-80 TreadmillEaton Medical GroupIOLClass I
K851629Tmx-70 TreadmillEaton Medical GroupIOLClass I
K851553Meriuaara & Eracare WheelchairsDaun International, Inc.IORClass I
K851550Merivaara Geriatric ChairDaun International, Inc.INMClass I
K851548Ahlbergs Kombi I & Kombi II Mobile Transfer ChairsDaun International, Inc.INMClass I
K851332Blhi Luteinizing HormoneEuro-Diagnostics BVCEPClass I
K851100Chem Pro 1000 Chemistry AnalysisSen Tech Medical Corp.CEMClass II
K850567Abbott Toxo-M Eia Diagnostic KitAbbott MedicalLGDClass II
K850390Cholesterol Test SystemHans J. Brouwers & Assoc.CHHClass I
K850020Pentax Pne- Ultra-Slim Upper G.i. Fiberscope Fg-23Pentax Precision Instrument Corp.FDSClass II
K844727Model 1000VeriteIPFClass II
K852601Servo Humidifier 153Siemens Elema ABBYDClass I
K852493Uncuffed Hi-Lo Jet Tracheal TubeMallinckrodt Critical CareBTRClass II
K852463Andros Analyzers Airway AdapterAndros Analyzers, Inc.CCKClass II
K852350Hdl Cholesterol PretreatmentAmerican Monitor Corp.LBRClass I
K852292Durazyme Urea NitrogenAmerican Monitor Corp.CDQClass II
K852272Bivona Tracheostoma Valve IIBivona Medical TechnologiesBTOClass II
K852096Resus-Aid Disposable Resuscitation ShieldEmergency Situation ProductsBTMClass II
K851905Lpa-2 Remote AlarmLife Products, Inc.CAPClass II
K851805Lpa-3 PrinterLife Products, Inc.BZCClass II
K851436Nebulaire (Irc 1040) Nebulizer PumpInvacare GmbHCAFClass II
K851415Body Analysis System (Deemed Se 87/09/18)Medi-Sport Testing, Inc.DSBClass II
K851271Legionella Culture Confirmatin KitHologic, Inc.GROClass II
K851197Cybermedic Cm-810 Body PlethysmographCybermedic, Inc.JEHClass II
K850084Trindium-Dental MaterialTrindium Corp. of AmericaEJHClass II
K852518Modification Fetal Monitor Model Fm-2Advantage Medical Systems, Inc.HGMClass II
K852507Nd: Yaglaser for Palliative Treat of ObstructionEndo Lase, Inc.LLOClass II
K852422Model 500 Pediatric Stretcher/cribMidmark CorpFMSClass II
K852373Ad150, Automated Hematology DilutorAbbott DiagnosticsGKHClass I
K852358Syringe Infusion Pump - as 20 SeriesBaxter Healthcare CorporationFRNClass II
K852357Gyne-Shear Cervical Biopsy Instrument W/dispis TipGyneco, Inc.HFBClass I
K852307Pulmonary Test System Fudac-30Futuremed Div. of Future Impex Corp.BZGClass II
K852136Precinorm HbBoehringer Mannheim Corp.GGMClass II
K852111Glyco-CheckThyroid Diagnostics, Inc.LCPClass II
K852107Sickle-ChexStreck Laboratories, Inc.
K852076Model 145 Fetal MonitorGE Medical Systems Information Technologies, Inc.HGMClass II
K851934Cytological Cervical Spatula the Multi-SpatulaTridak Division of Indicon, Inc.HHTClass II
K851869Dahlberg Model Dc Behind-the-Ear Hearing AidMiracle-Ear/Dahlberg, Inc.ESDClass I
K851867Dahlberg Model Dd Behing-the-Ear Hearing AidMiracle-Ear/Dahlberg, Inc.ESDClass I
K851866Dahlberg Model Db Behind-the-Ear Hearing AidMiracle-Ear/Dahlberg, Inc.ESDClass I
K851821VI-Flow Pump with VI-SetVital Canada, Inc.FRNClass II
K851810Model Da Behind-the-Ear Hearing AidMiracle-Ear/Dahlberg, Inc.ESDClass I
K851464Pulse Med Custom Pkg. Proc. Trays Operating RoomsPulse Med, Inc.FMFClass II
K851408Sun Flower Solette Minette Nova Super 28X, Pro SerApplied Science, Inc.FTCClass II
K851383Blisterfilm Transparent DressingChesebrough-Pond'S U.S.A. Co.NADClass I