MedSource Labs, LLC
Chanhassen, MN, US
MedSource Labs, LLC appears in FDA device records in Chanhassen, MN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for MedSource Labs, LLC between 2020 and 2026. The busiest year on record is 2026, with 2. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261041 | ClearSafe Closed System | FOZ | Substantially Equivalent | |
| K260539 | MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter | FOZ | Substantially Equivalent | |
| K193278 | MedSource CathMED IV Catheter | FOZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003674698 | 3003674698 | MedSource Labs, LLC | 8600 Shelby Court, Suite 100, Chanhassen, MN 55317 US | 2026 | and 56 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- BTQAirway, Nasopharyngeal
- CAEAirway, Oropharyngeal, Anesthesiology
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- FQMBandage, Elastic
- FNYBasin, Emesis
- KMEBedding, Disposable, Medical
- DXQBlood Pressure Cuff
- CATCannula, Nasal, Oxygen
- JOLCatheter And Tip, Suction
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- BSYCatheters, Suction, Tracheobronchial
- BZAConnector, Airway (Extension)
- MMKContainer, Sharps
- FLLContinuous Measurement Thermometer
- FMWCover, Mattress (Medical Purposes)
- BYWDevice, Rebreathing
- FMRDevice, Transfer, Patient, Manual
- NACDressing, Wound, Hydrophilic
- DRXElectrode, Electrocardiograph
- CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated
- NABGauze / Sponge,Nonresorbable For External Use
- CGAGlucose Oxidase, Glucose
- KCHHook, Tracheal
- LRSI.V. Start Kit
- MDMInstrument, Manual, Surgical, General Use
- CCWLaryngoscope, Rigid
- KYTLight, Examination, Medical, Battery Powered
- BYGMask, Oxygen
- KGBMask, Oxygen, Non-Rebreathing
- FXXMask, Surgical
- BYPMouthpiece, Breathing
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- GAANeedle, Aspiration And Injection, Disposable
- OEANon-Surgical Gown
- DQAOximeter
- IMDPack, Hot Or Cold, Disposable
- LKBPad, Alcohol, Device Disinfectant
- CANRegulator, Pressure, Gas Cylinder
- JOKScissors, Medical, Disposable
- FPASet, Administration, Intravascular
- LHISet, I.V. Fluid Transfer
- FPYSheet, Burn
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- ILISling, Arm
- ILHSplint, Hand, And Components
- FOXStand, Infusion
- LDEStethoscope, Manual
- FPPStretcher, Hand-Carried
- NZDStretcher, Patient Restraint
- FPOStretcher, Wheeled
- BSRStylet, Tracheal Tube
- CCXSupport, Patient Position
- NBWSystem, Test, Blood Glucose, Over The Counter
- KGXTape And Bandage, Adhesive
- GAXTourniquet, Nonpneumatic
- BTRTube, Tracheal (W/Wo Connector)
- JLLTubeless Analysis, Gastric Acidity
- CBPValve, Non-Rebreathing
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets MedSource Labs, LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain