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 3295 of 3528
510(k) clearances, page 3295 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K810513Electrodyn Cii-Interferential MuscleNemectron Medical, Inc.IPFClass II
K803154Instrument Cleaner Liquid ConcentrateAbco Dealers, Inc.
K811190Three Models of Tables, Stools, & LightsMidmark CorpLGXClass I
K811162Flowlock Oxygen MeterLifeguard Medical Products, Inc.BYJClass II
K811126Aim System (for Igg)Icl ScientificDEWClass II
K811125Aim System (for Iga)Icl ScientificCZPClass II
K811124Aim System (for Igm)Icl ScientificDFTClass II
K811111Automatic Elisa ReaderArtek Systems Corp.JJQClass I
K811091Minor Dressing TrayCunningham Woodland, Inc.LDQ
K811090Major Dressing TrayCunningham Woodland, Inc.LDQ
K811089One Step Prep KitCunningham Woodland, Inc.LDQ
K811088Dressing Tray Mercy HospitalCunningham Woodland, Inc.LDQ
K811024Luteinizing Hormone Direct Ria Kit 125/IImmunalysis CorporationCEPClass I
K811004ManifoldAmerican Pharmaseal Div. AhscDTZClass II
K811000Abnormal Glycosylated Hemoglobin ControlCorning Medical & ScientificLCPClass II
K810945Scanel 100Cgr Medical Corp.IYOClass II
K810915The Scott DialmenzensertLone Star Medical ProductsKOAClass I
K8109145Cm Small Parts ScannerSmithkline Diagnostics, Inc.IYOClass II
K810845Double Velour GraftsMeadox Medicals, Div. Boston Scientific Corp.DSYClass II
K810843EpilatronElectrolaKCWClass I
K810777Hanks' Balanced Salts Solution (Modif.)Dutchland Laboratories, Inc.KIPClass I
K810775Goat Serum-SterileDutchland Laboratories, Inc.KISClass I
K810767Rpmi 1640 MediumDutchland Laboratories, Inc.KITClass I
K810766Hanks' Balanced Salt Solution W/o Ca-MgDutchland Laboratories, Inc.KIPClass I
K810735Disposable, Sterile Transducer DomesBio-Med Corp.DRSClass II
K810714Lancer Glycosylated Hemoglobin AssaySherwood Medical Co.LCPClass II
K810711Haemonetics 600 Ml. Component BagHaemonetics CorporationKSRClass II
K810683Capd Catheter AdapterAmerican McgawFKXClass II
K810638Lancer Glycosylated HemoglobinSherwood Medical Co.LCPClass II
K810635Electrode Blood Pressure MonitorSears, Roebuck & Co.DSKClass II
K810488Home Health Chekup KitHealthkitKHEClass II
K802828LixivitronUnited Medical IncLIFClass II
K810297Datascope Percor=dl Dual-Lumen IntraDatascope Corp.DSPClass II
K811155Model Rxo2 Oxygen Rich Air SupplyGreene & Kellogg, Inc.CAWClass II
K811138Nutrient AgarNeogen Culture MediaJSQClass I
K811137Columbia Cna AgarNeogen Culture MediaJSJClass I
K811136Mueller Hinton BrothNeogen Culture MediaJTZClass II
K811135Columbia Blood Agar BaseNeogen Culture MediaJSGClass I
K811134Acu-Desoxycholate AgarNeogen Culture MediaJSIClass I
K811133Eosin-Methylene Blue AgarNeogen Culture MediaJSIClass I
K811132Eugon BrothNeogen Culture MediaJSCClass I
K811131Hektoen Enteric AgarNeogen Culture MediaJSIClass I
K811130Lactose BrothNeogen Culture MediaJSHClass I
K811129Lauryl Sulfate BrothNeogen Culture MediaJSIClass I
K811128Brucella AgarNeogen Culture MediaJSJClass I
K811120Surgical Staple RemoverAcme United Corp.KDCClass I
K811102Siemens-Elema Ab Servo Ventilator 900 CSiemens Elema ABCBKClass II
K811098Sero-Stat Staphylococcus TestScott Laboratories, Inc.JWXClass I
K811093Braegen EEG Transmitter/receiver SysElectro-Bio-Medical Services, Inc.GYEClass II
K811071Venous Oxygen ProbeG.D. Searle and Co.CCEClass II