MedSource Labs, LLC
Registration 3003674698FEI 3003674698Chanhassen, MN
Owner/operator: MEDSOURCE LABS, LLC
- Complaint File Establishment per 21 CFR 820.198
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Medical Device
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 81
- Added, last 12 months
- 5
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 81
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| CCK | Carbon dioxide sampling cannulaAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class 2 | 21 CFR 868.1400 | K143127 |
| GCX | Curaplex Yankauer without VentApparatus, Suction, Operating-Room, Wall Vacuum Powered | Class 2 | 21 CFR 880.6740 | — |
| DXQ | Match-complete setBlood Pressure Cuff | Class 2 | 21 CFR 870.1120 | K203620 |
| JOL | Suction CatheterCatheter And Tip, Suction | Class 2 | 21 CFR 880.6740 | — |
| FOZ | Standard IV CatheterCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | 21 CFR 880.5200 | K193278 |
| FOZ | MedSource ClearSafe Blood Control IV safety CatheterCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | 21 CFR 880.5200 | K223788 |
| FOZ | TrueSafe Blood Control IV Safety CatheterCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | 21 CFR 880.5200 | K161779 |
| FOZ | ClearSafe Blood Control IV Safety CatheterCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | 21 CFR 880.5200 | K150611 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital | Class 2 | 21 CFR 880.5200 | K131555 |
| FOZ | MedSource Passivo IV Safety CatheterCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysAdded Jul 14, 2026 | Class 2 | 21 CFR 880.5200 | K260539 |
| FOZ | ClearSafe Closed SystemCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysAdded Jul 14, 2026 | Class 2 | 21 CFR 880.5200 | K261041 |
| SDV | CLINICAL INFRARED THERMOMETERSClinical Electronic ThermometerAdded Jun 24, 2026 | Class 2 | 21 CFR 880.2910 | — |
and 69 more on your full dossier
What changed
- Jul 14, 2026Listing added: FOZ — MedSource Passivo IV Safety Catheter (K260539)
- Jul 14, 2026Listing added: FOZ — ClearSafe Closed System (K261041)
- Jun 24, 2026Listing added: SDV — CLINICAL INFRARED THERMOMETERS
- Dec 23, 2025Listing added: DRX — Electrodes
- Jun 10, 2026Listing added: OFX — Dental Kit