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 3008 of 3529
510(k) clearances, page 3008 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K850736Selective Culture MediumRoseville Medical LaboratoriesuJSIClass I
K850734Differential Culture MediumRoseville Medical LaboratoriesuJSEClass I
K850733Multipurpose Culture MediumRoseville Medical LaboratoriesuJSGClass I
K850732Culture Medium for Pathogenic Neisseria Ssp.miRoseville Medical LaboratoriesuJTYClass II
K850731Culture Medium for Antimicrobial Suscep. TestingRoseville Medical LaboratoriesuJTZClass II
K850718Corn Meal AgarRapid City Regional Hospital, Inc.JSHClass I
K850712Emit Qst Phenytoin Assay -Monoclonal AntibodySyva Co.DIPClass II
K850665Corneascope Model 1200Kera Corp.HLQClass I
K850658Campylobacter Blood-Free Selective Agar BaseOxoid U.S.A., Inc.JSGClass I
K850636Simutaneous Fixation & Decalcifying Solution Cal-EFisher Scientific Company L.L.C.KDXClass I
K850607Amdinocillin 10 Mcg Sensitivity DiscsDifco Laboratories, Inc.JTNClass II
K850537Cell Culture Refeed MediumHillcrest BiologicalsKITClass I
K850358Ceftriaxone 30 Mcg Sensi-DiscBD Becton Dickinson Vacutainer Systems PreanalyticJTNClass II
K850357Amdinocillin 10 Mcg Sensi-DiscBD Becton Dickinson Vacutainer Systems PreanalyticJTNClass II
K850308C.l.a.t.Pro-Lab, Inc.JSKClass I
K850307Campylobacter Supplement-Blaser/wangPro-Lab, Inc.JSKClass I
K850306Campylobacter Supplement -SkirrowPro-Lab, Inc.JSKClass I
K850301Yeast DialysatePro-Lab, Inc.JSKClass I
K850300MucolysePro-Lab, Inc.JSKClass I
K850299C.n.v.t.Pro-Lab, Inc.JSKClass I
K850127Forma-Tag Usp Sodium Chloride Package 80Gm & 120 GComputer Dialysis Systems, Inc.LIFClass II
K850099Visoprotect: Occular ShieldRockway Enterprises, Inc.HMPClass I
K850005Visoprotect Occular ShieldM.S.G. Health Systems, Inc.HMPClass I
K850788Glutamyltransferase Assay KitDiagnostic Chemicals, Ltd. (USA)JPZClass I
K850182Ivac Keofeed II Polyurethane Feeding TubeYKNTClass II
K850037Closed Wound DrainConsolidated Medical Equipment CompanyGCYClass I
K845042Abbott Inpersol Cycler 1000Abbott MedicalFKXClass II
K844955Seralyzer Potassium Reagent Strips, Test Module, &Miles Laboratories, Inc.CEMClass II
K844642Acculevel Theophylline TestSyva Co.KLSClass II
K842092Seralyzer Aris Phenytoin Reagent StripsMiles Laboratories, Inc.DIPClass II
K850776Preformed Dental Impression TraysL.A.K. Ent., Inc.EHYClass I
K850699Spartan -Alloy for Porcelain Fused to MetalWilliams Gold Refining Co., Inc.EJSClass II
K850641Caulk Dycal Light CuredDentsply Intl.EBDClass II
K850389Multiple Outlet ManifoldThe Anspach Effort, Inc.GEYClass I
K850288Hepatic Parenchymal Suction DissectorBeecher Medical Diagnostic InstrumentationGDIClass I
K845034Foremost Lite Cure Pit & Fissure SealantForemost Dental Mfg., Inc.EBCClass II
K845033Foremost Dentin AdhesiveForemost Dental Mfg., Inc.EBFClass II
K844973Irriga Suc Illum Isis 710 & 7100 SeriesVital Metrics, Inc.
K844943Weill Cementless Threaded Acetabular CupAdvanced Biosearch Assn.KWAClass III
K844925Perimeter Mediastinal DrainPerimeter Medical, Inc.
K844924Perimeter Yankauer Suction Tips & SetsPerimeter Medical, Inc.
K844923Perimeter Sump DrainPerimeter Medical, Inc.
K844922Perimeter Thoracic CatheterPerimeter Medical, Inc.GBXClass I
K844921Perimeter Closed Wound ResevoirPerimeter Medical, Inc.GCYClass I
K844889Mensink-Goosen CatheterGoosen Enterprises, Inc.GBPClass I
K844378Oil, MineralTreace Medical, Inc.
K844377SiliconeTreace Medical, Inc.
K850735Enriched Culture MediumRoseville Medical LaboratoriesuKZIClass I
K850072Custom Open Heart TrayPro-Lab, Inc.
K850798Amylase ProductsData Medical Associates, Inc.JFJClass II