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 2899 of 3529
510(k) clearances, page 2899 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K861886Dmem & Ham's F-12 (1:1) Powdered MediumHazleton Research Products, Inc.KITClass I
K861885Williams Medium E PowderHazleton Research Products, Inc.KITClass I
K861879Ck Reagent Cartridge (Product No. 88213)Hi Chem, Inc.CGSClass II
K861875Rpmi-1640 Medium with 25Mm Hepes BufferHazleton Research Products, Inc.KITClass I
K861874Minimum Essential Med. (Eagle) W/25mm Hepes BufferHazleton Research Products, Inc.KITClass I
K861873Mem Glasgow MediumHazleton Research Products, Inc.KITClass I
K861872Iscove's (Modified) Dulbecco's MediumHazleton Research Products, Inc.KITClass I
K861871Nctc 109 MediumHazleton Research Products, Inc.KITClass I
K861870Dulbecco's Modified Eagle Med. W/25mm Hepes BufferHazleton Research Products, Inc.KITClass I
K861869Gentamicin-50Mg/mlHazleton Research Products, Inc.KITClass I
K861868Williams Medium EHazleton Research Products, Inc.KITClass I
K861867Mem Alpha Eagle MediumHazleton Research Products, Inc.KITClass I
K861835Microtrak Neiserria Gonorrhoeae Culture TestSyva Co.GTHClass II
K861750Ck/ld Buffer (Cat. No. 5808)Helena Laboratories, Corp.CFEClass II
K861718Amylase Reagent Catalogue Nos. 85108 and 85109Reagents Applications, Inc.JFJClass II
K861712Wetting & Soaking Hard Contact Lens SolutionMaurry Biological Co.HPXUnclassified
K861675Acid Phosphatase ProcedureData Medical Associates, Inc.CKBClass II
K861672Gamma Glutamyl Transferase ProcedureData Medical Associates, Inc.JPZClass I
K861667Alkaline Phosphatase ProcedureData Medical Associates, Inc.CJEClass II
K861662Lactate Dehydrogenase (Ld) ProcedureData Medical Associates, Inc.CFJClass II
K861658Alt/gpt ProcedureData Medical Associates, Inc.CKAClass I
K861657Calcium ProcedureData Medical Associates, Inc.CICClass II
K861656Ast/got ProcedureData Medical Associates, Inc.CITClass II
K861652Iron ProcedureData Medical Associates, Inc.JIYClass I
K861651Total Bilirubin ProcedureData Medical Associates, Inc.CIGClass II
K861642Lenskeeper Contact Lens Carrying CaseAllerganHPXUnclassified
K861638Kinetic Alkaline Phosphatase Reagent KitBio-Analytics Laboratories, Inc.CJEClass II
K861424Adaptable Class III MaskGreat Lakes Orthodontics, Ltd.DZBClass II
K861397Ohmeda 5300 Anesthetic Agent MonitorGE HealthcareCBQClass II
K861394Emit Digoxin Mobile Phase SolutionSyva Co.KXTClass II
K861393Emit Column Digoxin AssaySyva Co.KXTClass II
K861367Kodak Ektachem Clinical Chemistry Slides (Theo)Eastman Kodak CompanyKLSClass II
K861269Raichem Amylase ReagentReagents Applications, Inc.JFJClass II
K861097Trypsin Ria KitMicroanalytic Research, Inc.JNOClass I
K861049High Molecular Weight Kininogen(hmwk) Def PlasmaSigma Chemical Co.GGPClass II
K861048Prekallikrein Deficient Plasma, Cat. No. B 6765Sigma Chemical Co.GGPClass II
K860906Stratus Immunoassay Controls, Levels I, II, IIIAmerican DadeJJYClass I
K860829Cns 4/8 and CT 48.1 SoftwareCns, Inc.GWSClass I
K860677Easy Eyes Tm Lens Carrying CaseApplied Laboratories, Inc.HPXUnclassified
K861732Storz E9050 & E9055 Diamond KnivesStorz Instrument Co.HNNClass I
K861605Schneider-Shiley Pressure ManometerShiley, Inc.KRKClass II
K861574Acs Hi-Torque Tapered Diameter Guide WireAdvanced Cardiovascular Systems, Inc.DQXClass II
K861545Irrigation/aspiration Cannulas, Various SizesRophae Lens Co., Inc.HMXClass I
K861491Rophae Diamond KnifeRophae Lens Co., Inc.HNNClass I
K861177Capiox III Cardiopulmonary Bypass OxygenatorTerumo Medical Corp.DTZClass II
K861116Toray Anthron Bypass TubesToray Industries (America), Inc.DWFClass II
K861103Chest Drainage Pack, Cdp-1000Gish Biomedical, Inc.DWFClass II
K861102Cps-3000 Cardioplegia ReservoirGish Biomedical, Inc.DTRClass II
K861085Elastic Lens Injector TmStaar Surgical AGKYBClass I
K860775Mediastinal Autotransfusion SystemCardio Metrics, Inc.DTPClass II