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 3084 of 3528
510(k) clearances, page 3084 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K840796Tender Lifting CareLancer Assoc.FRZClass II
K840696Lcd Digital ThermometerLtd Commodities, Inc.FLLClass II
K840680Centry 2000 Dialysis Control UnitCobe Laboratories, Inc.KDIClass II
K840611Dsl-150Shimadzu Corp.IYOClass II
K840601B2-Micro ControlPharmacia, Inc.JZGClass II
K840415HemocathQuinton, Inc.FIQClass II
K840356Ohio Unitrol II Anesthesia Gas MachineOhio Medical ProductsBSZClass II
K840248IV-FilterTri-Med, Inc.FPBClass II
K834576Real Fiber Optic Ureteral TransilluminDouglas Manufacturer Co.FFSClass II
K834468Drainage StentMicrovasiveFGEClass II
K834395ChemlyteDiachem LaboratoriesFKQClass II
K834335Ameda Phototherapy Lamp for NewbornEgnell, Inc.LBIClass II
K834141Ultrasound Scan Head 3.5 MhzAdr UltrasoundIYOClass II
K834116Deae-Dextran in PbsBartels Immunodiagnostic Supplies, Inc.KITClass I
K841442P-S Medical Csf-Flow Control Valve-P-S MedicalJXGClass II
K841108Aca Digoxin CallibratorE.I. Dupont de Nemours & Co., Inc.DLJClass II
K841107Aca Digoxin Analytical Test PackE.I. Dupont de Nemours & Co., Inc.KXTClass II
K841047Paramax Chloride ReagentAmerican DadeCHJClass II
K841042Matched Component Set RadioimmunoassayCambridge Medical TechnologyCDZClass I
K840985Trisacryl Gf 05 & Trisacryl Gf 2000Lkb Instruments, Inc.DJYClass I
K840977Liquid Chromatographic Detector Lc-95Revvity Health Sciences, Inc.KZRClass I
K840938High Speed DispenserMicromedic SystemsJQWClass I
K840829Kyotest UgkKyoto Diagnostics, Inc.JILClass II
K840738Plus Urine Hcg AssayMonoclonal Antibodies, Inc.JHJClass II
K840603Arterial Filter Purge Line W/check ValvShiley, Inc.DTLClass II
K840328Phase II Hcg KitMedical & Scientific Designs, Inc.JHIClass II
K840257Rapid Immuno-Assay SysApplied Polytechnology, Inc.LLGClass II
K840010Dade Hematology Calibrator PlusAmerican DadeKRZClass II
K834349Anti-Native DNA AntibodySigma Chemical Co.KTLClass II
K832721Digital Sphygmomanometer Ua-231Copal, Inc.DXNClass II
K841413Hydra-Gym Athletics Inc.Hydra Fitness IndustriesBXBClass I
K841412Rolled Neck W/tapWarne Surgical Products, Ltd.BTCClass I
K841411Rolled Neck W/plugWarne Surgical Products, Ltd.BTCClass I
K841410Bush Neck W/tapWarne Surgical Products, Ltd.DRMClass II
K841409Bush Neck W/plugWarne Surgical Products, Ltd.BYZClass II
K840959Free T3 Solid Phase RadioimmunoassayBD Becton Dickinson Vacutainer Systems PreanalyticCDPClass II
K840902Endab Estriol UnconjugatedIMMUNOTECH s.r.o.CGIClass I
K840887Amresco E2a Reagent Set 0562 & 0626American Research Products Co.CEMClass II
K840886Hydroxyprogesterone by Ria 17ARadioassay Systems Laboratories, Inc.JLSClass I
K840880Ektachem Clinical Chem. SlidesEastman Kodak CompanyCIGClass II
K840872Raichem Creatinine ReagentReagents Applications, Inc.CGXClass II
K840852Immpulse T4 Assay ReagentsParagon Diagnostics, Inc.CDXClass II
K840725Clinical Care StimulatorBiostim, Inc.
K840670Phadebas Rast Phadezym Mix AllergPharmacia, Inc.DHBClass II
K833387Argon Laser Surgical System 770Cooper Medical, SRL
K841429Mouth to Mask Emergency VentilationO-Two Systems Intl., Inc.CAEClass I
K841304Haemophilus Id Quad-PlateGibco Laboratories Life Technologies, Inc.JSIClass I
K841303Campylobacter Thioglycollate MedAnaerobe SystemsJSGClass I
K841209Selective and DifferentialSmith River BiologicalsJSIClass I
K841207Non-Selective & Non-DifferentialSmith River BiologicalsJSIClass I