510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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 3358 of 3526
510(k) clearances, page 3358 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K800765Centrifichem CholesterolUnion Carbide Corp.CHHClass I
K800763Miser Inhalation Device, Part No. 700Vix Breathing Equipment Co.CCQClass I
K800753Sterile Water & Saline in Plastic Btl.Travenol Laboratories, S.A.BTTClass II
K800739Rionet &/or Rion Hearing Aid Model Ha-82Rion Acoustic Instruments, Inc.ESDClass I
K800738Rionet &/or Rion Hearing Aid Mod. Hb-67SRion Acoustic Instruments, Inc.ESDClass I
K800736Pre-Dent SystemPre-Dent SystemKSSClass I
K800642Rapi/tex Aso Standard SerumCalbiochem-Behring Corp.GTQClass I
K800626Uri-Dip (R)Pharma-Medica of Scandinavia, Ltd.JXAClass I
K800623Jackson Esophageal Bougie, X-Ray OpaquePilling Co.KCDClass I
K800621Percutaneous Catheter Introducer AdapterNorton Performance Plastics Corp.DYBClass II
K800620Venous M/a Internal Jugular KitNorton Performance Plastics Corp.DYBClass II
K800619Thermodilution Catheter Intro. KitNorton Performance Plastics Corp.DYBClass II
K800618Single, 2&3 Way Solution Sets #14-070 EtNorton Performance Plastics Corp.DQOClass II
K800538Gamma Stick Cortisol Ria Kit/stick KitAlpha Gamma LaboratoryCGRClass II
K800537Gamma Stick Gentamicin Ria KitAlpha Gamma LaboratoryDJBClass II
K800451Gemeni Igg AssayElectro-Nucleonics Laboratories, Inc.DEWClass II
K800450Gemeni Igm AssayElectro-Nucleonics Laboratories, Inc.DAOClass II
K800404Medspec Operative Opthalmic KitMedi-SpecHMPClass I
K800147Flexible Linear Reducer F/mitral & Tric.UsifroidKRHClass II
K800806I.c.s. Mini & Small Fragment SetHowmedica Corp.HRSClass II
K800800Patellar Component for Lubinus PatellarWaldemar Link GmbH & Co. KGHTGClass II
K800781Fetal Bovine SerumBiolabs, Inc.KISClass I
K800776Testok-125Sorin Biomedica, Fiat, USA, Inc.CDZClass I
K800775Aldoctk-125Sorin Biomedica, Fiat, USA, Inc.CJMClass II
K800774RenctkSorin Biomedica, Fiat, USA, Inc.CIBClass II
K800770Slavo Cholesterol Stand. Diagnostic KitSclavo, Inc.JITClass II
K800757Il Model 1303 Ph/blood Gas AnalyzerInstrumentation Laboratory Co.CHLClass II
K800752Pre-Padded Plaster/paris Band/splintsOrtho-Care, Inc.ITGClass I
K800720Macomb Nad-Nicotinamide Adenine DinucleoMacomb Chemical Co.
K800669Feldman Mini-Saw, #300000Karl Storz Endoscopy-America, Inc.EWQClass I
K800648Cadwell 7200Cadwell Laboratories, Inc.IKNClass II
K800640Medical Compartment Knee ProsthesisDow Corning WrightHSXClass II
K800557Disposable Pre-Gelled ElectrosurgicalVxtra Corp.GEIClass II
K800376Epr-200 Programmer Model 010Biotronik Sales, Inc.KRGClass III
K800756Dunrich TablesDunrich, Inc.ETFClass I
K800743Tobramycin Ria KitAntibodies, Inc.KLBClass II
K800741Central Vein Catheterization KitMedical Components, Inc.DQOClass II
K800740Prolactin Ria KitAmersham Corp.CFTClass I
K800728Paparell Type 2, Biolite Coated Sili-Xomed, Inc.ETDClass II
K800727Goode T-Tube, Biolite Coated Silicone/tuXomed, Inc.ETDClass II
K800724Ames Lab Management SystemMiles Laboratories, Inc.JQPClass I
K800717Topical Cooling Dev. Tcd. #27-999Cobe Laboratories, Inc.DTRClass II
K800708Code Qas.105 Prolactin Control SeraAmersham Corp.JJXClass I
K800706Medi-Trace Disposable Domes/monitoringGraphic Controls Corp.DRSClass II
K800705Medi-Trace Transducers/physiolog. MonitoGraphic Controls Corp.DRSClass II
K800700Amerlex Cortisol Ria KitAmersham Corp.CGRClass II
K800693Stanbio Prostatic Acid Phosphatase TestStanbio LaboratoryCKEClass II
K800671Smac Replacement Reagents-Wash SolutionsDiagnostic Solutions, Inc.
K800670Smac Replacement Reagents, Wetting AgentDiagnostic Solutions, Inc.
K800667Monitemp Blood Pack Temp. MonitorLiquid Crystal Products, Inc.KSEClass II