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 3261 of 3528
510(k) clearances, page 3261 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K812810Pentax Flexible DriodenofiberscopePentax Precision Instrument Corp.FAKClass II
K813083Venofix Scalp Vein SetBurron Medical Products, Inc.FPAClass II
K813077Technicon Ra 1000 SystemTechnicon Corp.JJCClass I
K813076Phosphotungstate Reduction, Uric AcidAmerican Monitor Corp.CDHClass I
K813069Peritoneal Dialysis Cycler SetAmerican Medical Products LLCKDJClass II
K813066Argyle Yankauer Suction TubeSherwood Medical Co.GCXClass II
K813059Leeco Testo-Quant Diag. KitLeeco Diagnostics, Inc.CDZClass I
K813053Disposable Blood Pressure Transducer DomBentley Laboratories, Inc.DRSClass II
K813019Percutaneous Introducer: Seldinger StyleDip, Inc.DYBClass II
K813010EEG Telephone Transmitter, Model #T-7Pharmaquest Corp.GYEClass II
K812999Pet Polyethylene Torque CatheterUniversal Medical Instrument Corp.DQOClass II
K812991Intermedics Polyflex-Model 483-04 LeadIntermedics, Inc.DTBClass III
K812990Intermedics Polyflex-Model 483-03 LeadIntermedics, Inc.DTBClass III
K812989Intermedics Polyflex-Model 493-03 LeadIntermedics, Inc.DTBClass III
K812977Respiratory Care MonitorAdvanced Medical Equipment, Inc.BZAClass I
K812975Lancer Coagent Human Vactor VIII PlasmaSherwood Medical Co.GGPClass II
K812974Lancer Coagent Human Factor 1X PlasmaSherwood Medical Co.GGPClass II
K812973Percutaneous Introducer Cournand StyleDip, Inc.DYBClass II
K812964Introducer, Percutaneous SeldingerTriad Medical DivisionDYBClass II
K812960East Ventilarm Pressure Monitor Alarm S.Cairco, Ltd.CAPClass II
K812944Millar Mikro-Tip Catheter Pressure Tran.Millar LLC.DRFClass II
K812935Fogarty Flexible ProbeAmerican Edwards LaboratoriesDWPClass II
K812890Hemasite Graftless Vascular AcessRenal Systems, Inc.FIQClass II
K812886Endodontic Paper PointsUnited Dental Mfg., Inc.EKNClass I
K812873Medicon #8200 AmsMedicon Co., Ltd.BZQClass II
K812845Surgical Suction Instruments-Dispos.Abco Dealers, Inc.GCXClass II
K812828Model 2000 MonitorDatascope Corp.DRTClass II
K812827Orbic* Spherical AlloyJohnson & Johnson Professionals, Inc.EJJClass II
K812822Rind AirwayRind Medical DevelopmentCAEClass I
K812785Vance-Ambrose Resectoscope ForcepsVance Products, Inc.GENClass I
K812765Datascribe #Ds-40Timeter Instrument Corp.BXWClass I
K812755Model 535-03 Trace a PaceIntermedics, Inc.DXHClass II
K812743Fetal Vitability Tm ModeTechnicare Corp.IYOClass II
K812738Boundary Process ChangeThe Buckeye Cellulose Corp.KKXClass II
K812725Model 5867-12 Bipolar Low-Profile LeadMedtronic, Inc.LDFClass II
K812706Miller/nadler Glare TesterMosebach Electric & SupplyHOSClass I
K812691Silicone ImplantsSutter Biomedical, Inc.MDMClass I
K812646Ski 5000Smithkline Diagnostics, Inc.DXKClass II
K812643Lifespan CO2Biochem International, Inc.CCKClass II
K812638Diagnostic Medical ComputerDiagnostic Resources, Inc.DXGClass II
K812555Disposable Suture Removal ScissorsMedcare ProductsJOKClass I
K812464Synthemed Pulse Generator Vvi Model 1000Synthemed Corp.DXYClass III
K812389Surgical LoopsBerkeley MedevicesGADClass I
K812388Surgical PawsBerkeley MedevicesGDJClass I
K812331Vts-1000 Visual Testing SystemNicolet Biomedical InstrumentsHLXClass II
K812323Pds* Absorbable Ligating ClipsEthicon, IncFZPClass II
K812301Variable Focus 3.5 Mhz TransducerAdr UltrasoundITXClass II
K812219Model 900S Intraocular ProbeLumenis LtdHQFClass II
K812209Ultra ComUltranamics, Inc.DXKClass II
K812121Digiclot 2-#820Volu Sol Medical IndustriesJPAClass II