510(k) Report

FDA applicant

MedSource Labs, LLC

Chanhassen, MN3 decisions2020–20260 recalls

FDA records 3 decisions for MedSource Labs, LLC (Chanhassen, MN) from 2020 to 2026: 3 510(k) clearances. All are in product code FOZ (Catheter, Intravascular, Therapeutic…). Since 2016 its 510(k)s took a median of 142 days from receipt to decision, against 203 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medsource Labs”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided MedSource Labs, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 12026 (partial year): 2
2020high 2 (2026) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — MedSource Labs, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 142 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 203 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K261041ClearSafe Closed SystemMedSource Labs, LLC · 2026
  • K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC · 2026
  • K193278MedSource CathMED IV CatheterMedsource Labs · 2020

All 2 as MedSource Labs, LLC →The one decision as Medsource Labs →

Other applicant names beginning “MedSource”

FDA records each applicant name separately; these may or may not be the same firm.

Medsource International, LLC 10