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Data / Medical devices / United States / MedSource Labs, LLC

MedSource Labs, LLC: FDA-registered device maker in Chanhassen, MN, United States, 27 510(k) clearances

MedSource Labs, LLC is registered with the FDA (registration 3003674698) in Chanhassen, MN, United States. It lists 66 device types. The FDA files 27 510(k) clearances under its listings, the newest dated July 10, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch MedSource Labs, LLC
FDA registration number
3003674698
Address
8600 Shelby Court, Suite 100, Chanhassen, MN, United States, 55317
Owner or operator
MEDSOURCE LABS, LLC (9050135)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed
January 14, 2009
Registered through
2026
Brand names listed
11 Point Strap, ABD pads, Adaptor, Adaptor Universal, Aerosol Mask Elongated, Aerosol Mask Under Lip No Tubing, Aerosol Mask under chin, Alcohol Prep Pads and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Complaint file establishmentaccessdata.fda.gov
Airway, NasopharyngealBTQ1Complaint file establishmentaccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Complaint file establishment, Specification developeraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Complaint file establishmentaccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Complaint file establishmentaccessdata.fda.gov
Bandage, ElasticFQM1Complaint file establishmentaccessdata.fda.gov
Basin, EmesisFNY1Complaint file establishmentaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Complaint file establishment, Specification developeraccessdata.fda.gov
Blood Pressure CuffDXQ2Complaint file establishmentaccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Complaint file establishmentaccessdata.fda.gov
Catheter And Tip, SuctionJOL2Complaint file establishmentaccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2Complaint file establishment, Specification developeraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Complaint file establishmentaccessdata.fda.gov
Clinical Electronic ThermometerSDV2Complaint file establishmentaccessdata.fda.gov
Connector, Airway (Extension)BZA1Complaint file establishmentaccessdata.fda.gov
Container, SharpsMMK2Complaint file establishment, Specification developeraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Complaint file establishmentaccessdata.fda.gov
Cover, Mattress (Medical Purposes)FMW1Complaint file establishmentaccessdata.fda.gov
Device, RebreathingBYW1Complaint file establishmentaccessdata.fda.gov
Device, Transfer, Patient, ManualFMR1Complaint file establishment, Specification developeraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Complaint file establishmentaccessdata.fda.gov
Electrode, ElectrocardiographDRX2Complaint file establishmentaccessdata.fda.gov
Flowmeter, Tube, Thorpe, Back-Pressure CompensatedCAX1Complaint file establishmentaccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Complaint file establishmentaccessdata.fda.gov
General Purpose Dental TrayOFX1Complaint file establishment, Manufactureraccessdata.fda.gov
Glucose Oxidase, GlucoseCGA2Complaint file establishmentaccessdata.fda.gov
Hook, TrachealKCH1Complaint file establishmentaccessdata.fda.gov
I.V. Start KitLRS2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Complaint file establishment, Specification developeraccessdata.fda.gov
Laryngoscope, RigidCCW1Complaint file establishment, Specification developeraccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Complaint file establishmentaccessdata.fda.gov
Mask, OxygenBYG1Complaint file establishmentaccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Complaint file establishmentaccessdata.fda.gov
Mask, SurgicalFXX2Complaint file establishmentaccessdata.fda.gov
Mouthpiece, BreathingBYP1Complaint file establishmentaccessdata.fda.gov
Multiple Use Blood Lancet For Single Patient Use OnlyQRL2Complaint file establishmentaccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Complaint file establishmentaccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Complaint file establishment, Specification developeraccessdata.fda.gov
Non-Surgical GownOEA1Complaint file establishmentaccessdata.fda.gov
OximeterDQA2Complaint file establishmentaccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Complaint file establishmentaccessdata.fda.gov
Pad, Alcohol, Device DisinfectantLKBUComplaint file establishmentaccessdata.fda.gov
Personal Protection KitPXC1Complaint file establishmentaccessdata.fda.gov
Recorder, Paper ChartDSF1Complaint file establishmentaccessdata.fda.gov
Regulator, Pressure, Gas CylinderCAN1Complaint file establishmentaccessdata.fda.gov
Scissors, Medical, DisposableJOK1Complaint file establishmentaccessdata.fda.gov
Set, Administration, IntravascularFPA2Complaint file establishmentaccessdata.fda.gov
Set, I.V. Fluid TransferLHI2Complaint file establishment, Specification developeraccessdata.fda.gov
Sheet, BurnFPY1Complaint file establishmentaccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Complaint file establishmentaccessdata.fda.gov
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention FeatureQRK2Complaint file establishmentaccessdata.fda.gov
Sling, ArmILI1Complaint file establishment, Specification developeraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Complaint file establishmentaccessdata.fda.gov
Stand, InfusionFOX1Complaint file establishmentaccessdata.fda.gov
Stethoscope, ManualLDE1Complaint file establishmentaccessdata.fda.gov
Stretcher, Hand-CarriedFPP1Complaint file establishmentaccessdata.fda.gov
Stretcher, Patient RestraintNZD1Complaint file establishmentaccessdata.fda.gov
Stretcher, WheeledFPO2Complaint file establishmentaccessdata.fda.gov
Stylet, Tracheal TubeBSR1Complaint file establishment, Specification developeraccessdata.fda.gov
Support, Patient PositionCCX1Complaint file establishmentaccessdata.fda.gov
System, Test, Blood Glucose, Over The CounterNBW2Complaint file establishmentaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Complaint file establishmentaccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Complaint file establishmentaccessdata.fda.gov
Tube, Tracheal (W/Wo Connector)BTR2Complaint file establishment, Specification developeraccessdata.fda.gov
Tubeless Analysis, Gastric AcidityJLL1Complaint file establishmentaccessdata.fda.gov
Valve, Non-RebreathingCBP2Complaint file establishment, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 10, 2026K261041ClearSafe Closed SystemFOZSubstantially EquivalentMedSource Labs, LLCaccessdata.fda.gov
July 9, 2026K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterFOZSubstantially EquivalentMedSource Labs, LLCaccessdata.fda.gov
September 15, 2023K223788The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety CatheterFOZSubstantially EquivalentMedsource International, LLCaccessdata.fda.gov
January 20, 2023K222889FlowArt® Needle-Free Split Septum ValveFPASubstantially EquivalentAsset Medikal Tasarim San Tic As.accessdata.fda.gov
September 7, 2022K222034RightLance Blood Lancing SystemQRLSubstantially EquivalentBeijing Ruicheng Medical Supplies Co., Ltd.accessdata.fda.gov
June 7, 2021K210433Surgical Face Mask (Ear loops and Tie-on)FXXSubstantially EquivalentWuhan Dymex Healthcare Co., Ltd.accessdata.fda.gov
March 23, 2021K203620Aneroid SphygmomanometerDXQSubstantially EquivalentWuxi Exanovo Medical Instrument Co., Ltd.accessdata.fda.gov
October 23, 2020K201843Infrared ear and forehead thermometer, model YI-100FLLSubstantially EquivalentWenzhou Yosun Medical Technology Co.,Ltdaccessdata.fda.gov
August 7, 2020K193278MedSource CathMED IV CatheterFOZSubstantially EquivalentMedsource Labsaccessdata.fda.gov
January 3, 2019K180984Maxcon Sharps ContainerMMKSubstantially EquivalentNingbo Maxcon Medical Technology Co., Ltd.accessdata.fda.gov
July 23, 2018K171888Non-contact infrared body thermometerFLLSubstantially EquivalentHetaida Technology Co., Ltd.accessdata.fda.gov
February 13, 2018K172870Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100JFLLSubstantially EquivalentHangzhou Hua'An Medical&Health Instruments Co.,Ltdaccessdata.fda.gov
November 3, 2016K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterFOZSubstantially EquivalentMedsource International, LLCaccessdata.fda.gov
October 5, 2016K161560Fingertip Pulse Oximeter MD300CN310DQASubstantially EquivalentBeijing Choice Electronic Technology Co., Ltd.accessdata.fda.gov
July 15, 2015K150611MedSource ClearSafe Safety IV CatheterFOZSubstantially EquivalentMedsource Internationalaccessdata.fda.gov
May 8, 2015K150333MedSource Sharps DartMMKSubstantially EquivalentMedsource International, LLCaccessdata.fda.gov
February 13, 2015K143127CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only styleCCKSubstantially EquivalentDispo-Med (Malaysia) Sdn Bhdaccessdata.fda.gov
August 29, 2014K142097SELEC-3 I.V.ADMINISTRATION SETFPASubstantially EquivalentBiomedix, Inc.accessdata.fda.gov
April 22, 2014K140442MEDSOURCE SELECTABLE IV SETLHISubstantially EquivalentMedsource International, LLCaccessdata.fda.gov
April 3, 2014K140402MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SETLHISubstantially EquivalentMedsource International, LLCaccessdata.fda.gov
January 31, 2014K131555MEDSOURCE IV SAFETY CATHETERFOZSubstantially EquivalentMedsource International, LLCaccessdata.fda.gov
July 11, 2012K120424MEDSOURCE IV ADMINSTRATION SETLHISubstantially EquivalentMedsource International, LLCaccessdata.fda.gov
May 10, 2010K093327INTCO TAB ELECTRODEDRXSubstantially EquivalentShanghai Intco Electrode Manufacturing Co., Ltd.accessdata.fda.gov
December 7, 2009K082965DS-A BLOOD GLUCOSE MONITORING SYSTEMCGASubstantially EquivalentAlliance International Co., Ltd.accessdata.fda.gov
October 8, 2009K090361REMOTE INFRARED THERMOMETER, MODEL RC002FLLSubstantially EquivalentRycom Electron Technology Limitedaccessdata.fda.gov
October 27, 2008K080339MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)BTRSubstantially EquivalentMedsource International, LLCaccessdata.fda.gov
August 26, 2008K081516MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORTCBPSubstantially EquivalentMedsource International, LLCaccessdata.fda.gov

Compare with other makers

Updated July 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.