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 3350 of 3526
510(k) clearances, page 3350 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K800902Bun-Color 2, Blood Urea Nitrogen TestSclavo, Inc.CDLClass II
K801260Disposable Pressure Line AdaptorIntec Medical, Inc.BYXClass I
K801258Needle Counter-Sure Count/10 CountKleen Test Products CorporationBXXClass I
K801257Needle Counter-Sure Count/30 CT. Magn.Kleen Test Products CorporationBXXClass I
K801256Needle Counter-Sure Count-Disposa-TrayKleen Test Products CorporationBXXClass I
K801255Penlon Jumbo Carbon Dioxide AbsorberPenlon, Ltd.BSFClass I
K801252Nebulizer with Air Entertainer & Etc.Airlife, Inc.BTTClass II
K801251Non-Conductive, Single Use Face Mask #55Vital Signs, Inc.BSJClass I
K801240Built-in Temperature MonitoringBentley Laboratories, Inc.DTZClass II
K801229Bondalcap (Carboxylate)Vivadent (USA), Inc.EMAClass II
K801228Bondalcap (Silico-Phosphate)Vivadent (USA), Inc.EMAClass II
K801215Abco Pediatric StethoscopeAbco Dealers, Inc.LDEClass I
K801200Sampling Manifold H530C.R. Bard IncDTLClass II
K801199Voldyne Volumetric Incentive Deep Br. ExChesebrough-Pond'S U.S.A. Co.BWFClass II
K801189Conphar Supertone StethoscopeConphar, Inc.DQDClass II
K801185Conphar Bowls StethoscopeConphar, Inc.LDEClass I
K801184Conphar Sprague Rappaport StethoscopeConphar, Inc.LDEClass I
K801183Conphar Dual Head StethoscopeConphar, Inc.LDEClass I
K801182Conphar Wall Model Mercury Sphygmoman.Conphar, Inc.DXQClass II
K801147Pediatric Arterial Blood Filter #Af-5Bentley Laboratories, Inc.DTMClass II
K801146Sampling KitPharmaseal LaboratoriesCBTClass I
K801078Perfectemp Ophthalmic CauteryMedical Products Development, Inc.HQPClass II
K801062Behind-the-Ear Hearing Aid Series GMaico Hearing Instruments, Inc.ESDClass I
K801060High Resolution 10Cm Diag. Ultra. ScanneSmithkline Diagnostics, Inc.IYOClass II
K801056Edp 1200 Ultrasonic B-ScannerTechnicare Corp.IYOClass II
K801053Pulsed Galvanic Stimulator, 450-DynamaxU.S. Medical Corp.IPFClass II
K801036Surgical MaskAmerican Threshold Industries, Inc.FXXClass II
K801009Howmedica White C&b AlloyDental Laboratory Products Div.EJSClass II
K800950Tanit Home Suntanning UnitTanit, Inc.FTCClass II
K800940Audionics Pb Max Hearing AidAudionics Corp.ESDClass I
K800904Tonotest Blood Pressure MonitorRetlif, Inc.DXNClass II
K800838Arcolith 3022&Arcolith 3023 Cardiac Gen.Arco Medical Products Co.DXYClass III
K800779Omniton Mt80-a Body Hearing AidBosch Hearing Instruments, Inc.ESDClass I
K800744Suntana Sunbed #Sb-1 & Sunbrella #Su-1Sun Ind., Inc.LEJClass II
K800725A-Gent Quantichrom Thrombigen IAbbott MedicalGGWClass II
K800592Sun Scene Tan BoothSun Scene International, Inc.
K792301Lifeline Tle J-Shaped Atrial EndocardialIntermedics, Inc.DTBClass III
K792300Lifeline Tle (Traebecular Lodging ElecIntermedics, Inc.DTBClass III
K801044Ames Glucometer Reflect. PhotometerMiles Laboratories, Inc.JJQClass I
K801008Multi-Ad Fluid Dispensing Pump Mp-3000Burron Medical Products, Inc.KYXClass I
K800989Dynawasher IIDynatech Laboratories, Inc.JTCClass I
K800987Mueller Hinton AgarQuality Assurance Laboratory, Inc.JTZClass II
K800986Trypticase Soy Agar W5% Sheep BloodQuality Assurance Laboratory, Inc.JSGClass I
K800908Capik-Candida Albicans Ident. Kit.IMMY, Inc.JXBClass I
K801217Skil-Care Gel Wedge, Flotation PadSkil-Care Corp.KICClass I
K801214Hamilton Tuckaway DeskMizuho Orthopedic Systems IncKNOClass I
K801212Wrights Rapid StainMcb Manufacturing Chemists, Inc.IAFClass I
K801179Flow Med 160D.R.O. Medical, Inc.FPAClass II
K801143Volu-Sol Urinary Dichrome StainVolu Sol Medical IndustriesIDAClass I
K801134MicrovacProgress Mankind TechnologyJOLClass II