510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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
45,902 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 3437 of 3526
510(k) clearances, page 3437 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K781238Kidney, Artificial, C-Dak 1.5Cordis US Corp.DJCClass II
K781237Kidney, Artificial, C-Dak 2.0Cordis US Corp.DJCClass II
K781236Enterotube IIHoffmann-La Roche, Inc.JSSClass I
K781225Globulin Test, Human Thyroxine BindingHyland Therapeutic Div., Travenol LaboratoriesCEEClass II
K781219Econ-O2Mountain Medical Equipment, Inc.
K781215Test Module Model Dm-352Extracorporeal Medical Specialities, Inc.
K781172U-Drape, BoundaryProcter & Gamble Mfg. Co.KKXClass II
K781169ImageDeringer-Ney, Inc.EJTClass II
K781168Generator, Pulse, PacemakerVitatron Medical BVDXYClass III
K781152Electrocardiographic ECG RecorderCardio-Dynamics Laboratories, Inc.DSMClass I
K781151ReprosilDentsply Intl.ELWClass II
K781148Electrosurgical Pencil SystemMedical Plastics, Inc.GEIClass II
K781129Accessory to 4-24 RecorderOxford Medilog, Inc.GWQClass II
K781122Lipoprotein StainElectrophoresis Corp. of AmericaHZGClass I
K781111Lead Conversion Kit, Model 341Edwards Pacemaker Systems
K781108Microcult-Gc Culture TestMiles Laboratories, Inc.JSXClass I
K781083Dental Silicone Impression MaterialCrown Delta Corp.ELWClass II
K781074Oxygen Rich Air Supply Unit-Model 390XorboxCAWClass II
K781039Oxy-on Digital Oxygen TimerChambers & Sadler Mfg.BXPClass I
K781006Immunochemistry Sys. Manual ModeBeckman Instruments, Inc.JZWClass I
K780953Model 1861 Blood PumpMedtronic, Inc.KFMClass II
K780952Model 1812 Control Console, AccessoriexMedtronic, Inc.DWAClass II
K780937Model 20 Digital Pulse Rate MonitorSentronix, Inc.DRTClass II
K780932Model 80 Conductivity/temp.test UnitWestern Laboratories Corp.FIZClass II
K780246Pacemaker, Electrode, Permanent & Temp.Daig Corp.DTBClass III
K760897Sterile Urethral Catheter KitDiamed Division Ill. Tool Works, Inc.KODClass II
K781398Teca Vs6 Video StimulatorTeca, Inc.GWEClass II
K781221Dilution Kit, Thermal, Cold PacInstrumentation Laboratory Co.DRCClass II
K781144Analyzer, Pacer System, Psa-5Edwards Pacemaker SystemsDTCClass II
K781130Accessory to ECG Analysis Sys.Oxford Medilog, Inc.OMCClass II
K781058C-Dak 4000 Artificial KidneyCordis US Corp.FJIClass II
K780896Needles, Design Change, IV CathetersJelco LaboratoriesGCBClass I
K780850Searle Neonatal Oxygen ProbeWill Ross Co.CCEClass II
K780848Portable Closed Wound Suction EvacuatorZimmer GmbHGCYClass I
K781408Rid System-(Acp) TestIcl ScientificDEMClass II
K781403Fta-ABS Test SystemZeus Scientific LLCGMSClass II
K781391Pbs for Fa (46-991-49)Flow Laboratories, Inc.KIPClass I
K781389Biomet Concentric Hex ScrewZimmer GmbHJDOClass II
K781388F.a. Mounting MediumFlow Laboratories, Inc.KEQClass I
K781384Wright Rapid StainMfg Chemists, Inc.IAFClass I
K781372Liquid T.b.c. MediumGibco Laboratories Life Technologies, Inc.JSCClass I
K781356Implant, Eye SphereMcghan Medical Corp.HPZClass II
K781347Camco Quik Stain IICambridge Chemical Products, Inc.IAFClass I
K781344Option Pho/sonic B-Mode ScannerG.D. Searle and Co.IYOClass II
K781311Electrode, Needle, CfmApplied Medical ResearchGXZClass II
K781281Cement, Dental/cavity LinerStar Dental Mfg. Co.EMAClass II
K781253Bun (Urease) ReagentCoulter Electronics, Inc.CDNClass II
K781242Alloy, Amalgam, Disp. CapsuleLee PharmaceuticalsEJJClass II
K781217Data Terminal Model 722Corning Medical & ScientificJQPClass I
K780966Lee-Alloy Disposable CapsulesLee PharmaceuticalsDZSClass I