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 2998 of 3529
510(k) clearances, page 2998 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K851108Volkman Retractor 699-576 Pcs. Sharp-4 Prongs Ss42The Huxley Instrument Corp.GADClass I
K851106Pratt-Smith T Forceps 1830-40 Pcs. Ss 420 or 420FThe Huxley Instrument Corp.GENClass I
K851099Igm Rheumatoid Factor Test KitBreit Laboratories, Inc.DHRClass II
K851098Behring Vector PhotometerBehring Diagnostics, Inc.JJQClass I
K851047Plastic Tube Extention SetMedovations, Inc.
K850880Horizon 1000 Cardiac MonitorMennen Medical, Inc.DRTClass II
K850879Horizon 2000 Physiological Patient MonitorMennen Medical, Inc.DSKClass II
K850702Cardiovit Cs-6 ECG-RecorderSchiller, AGDPSClass II
K850637Exothermic Heating PadTravenol Laboratories, S.A.IMDClass I
K8506021870T Pressure Transducer Pre-Amplifier, 1880 WateLife-Tech Intl., Inc.FAPClass II
K850601Model 1712 Catheter Withdrawal Sys for Urethral PrLife-Tech Intl., Inc.FAPClass II
K850559Pressure Relief AdaptorPrecision Medical, Inc.CAXClass I
K850465Cervical Collars & Head HaltersAbco Dealers, Inc.IQKClass I
K850388Iti 200 Electric Motor Drive, Univ.-Wheelchair AccInstrument Technology, Inc.
K850374Connection Cable for Synchronization of Two ServoSiemens Elema ABCBKClass II
K850352Micro-Struc. Acetabular Compon- Mc2pOsteonics Corp.JDLClass III
K850314Television Control Option 1220Rehab Technology, Inc.IQAClass II
K850313Television Control Option 1219Rehab Technology, Inc.IQAClass II
K850274Sutter Cpm 9000 -Nonmeasuring Exercise EquipmentSutter Biomedical, Inc.BXBClass I
K850178Dalton Folding WheelchairsDalton Instrument Corp.IORClass I
K850126Oil Emulsion Non-Adhering DressingAbsorbent Cotton Co., Inc.FROUnclassified
K850030Concentrical Continuous Passive Motion MachineArc Motion, Ltd.BXBClass I
K851340Blue Seal II Sterilization PouchAmerican Sterilizer Co.FRGClass II
K851228General Diagnostics Augmentin 30Mcg Suscep DiskWarner-Lambert Co.JTNClass II
K850765Strep-KitCulture Kits, Inc.JSJClass I
K850420Churchill Haber Point Needle Admin. SetChurchill Corp.FMIClass II
K850394Lemaitre Retrograde Valvulotome-Manu-Surgica InstrVascutech, Inc.DWSClass I
K843751Cordia Hs Antibody Typing ReagentsCordis US Corp.GQNClass II
K850572Hgm, Inc. Medical Laser Endocoagulator Model 8-KHgm, Inc.HQFClass II
K850055Profile Femoral HipDepuy, Inc.KWAClass III
K850050Pms Ophthalmology Pack-Pms Eye Tray/packProfessional Medical ServicesHOZClass II
K843995Tf-II Hip ProsthesisDow Corning Corp. Healthcare Industries MaterialsKWLClass II
K851364Franzen Needle Guide for Transrectal Prostate BiopPrecision Dynamics CorporationKNWClass II
K851344Oxidative Formentive MediumMicro Media LaboratoriesJSHClass I
K851250Septi-Chek Tsb W/sucrose Blood Culture Bottle-RochRoche Diagnostic Systems, Inc.JSGClass I
K851249Septi-Chek Schaedler Med. Blood Culture Bottle-RocRoche Diagnostic Systems, Inc.JSJClass I
K851214T-ScrewNortheast Iowa PodiatryHWCClass II
K851056Opaquer/bonding AgentDentsply Intl.KLEClass II
K851045Dent-Dr. Vacu-FrameDent-Dr.EIEClass I
K850965Kulzer Dentin AdhesiveKulzer GmbHEBFClass II
K850489Endosopic Stene Manipulating BalloonMill-Rose LaboratoryLQRClass II
K850194Caffeic Acid DiskRemel IncJSFClass I
K850169Eris Uro-Diagnostic SystemEris Medical TechnologyFFGClass II
K850012Allotropat/heyltex Corp. Bone Grafting Dense HydroHeyltex Corp.LYCClass II
K844916Model 518 & 519 Ultrasonoscope W/dopplerHoffrel Instruments, Inc.IYOClass II
K844774Effner Fiber Optic Cables for Cold Light TransmissMecron Medical Products, Inc.FCRClass II
K843792Van Jon Super Clyster(kit, EnemaVan Jon Co.FCEClass I
K851348Coba AgarMicro Media LaboratoriesJSJClass I
K851347Kanamycin-Vancomycin-Laked Blood AgarMicro Media LaboratoriesJSJClass I
K851346Phenylalanine AgarMicro Media LaboratoriesJSHClass I