FDA applicant

Medsource International, LLC

Mound, MN10 decisions2008–20230 recalls

FDA records 10 decisions for Medsource International, LLC (Mound, MN) from 2008 to 2023: 10 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and LHI (Set, I.V. Fluid Transfer). Its devices cite 14 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

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

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 International, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2008high 3 (2014) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Medsource International, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medsource International, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Medsource”

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

MedSource Labs, LLC 3

Medsource International, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Medsource”