510(k) Report

FDA applicant

Mueller Medical International, LLC

Foster, RI1 decision2013–20130 recalls

FDA records 1 decision for Mueller Medical International, LLC (Foster, RI) in 2013: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

How often FDA has decided Mueller Medical International, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Mueller Medical International, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K123904ProthelialMueller Medical International, LLC · 20131cites it

What has FDA decided for it lately?

  • K123904ProthelialMueller Medical International, LLC · 2013

The one decision as Mueller Medical International, LLC →

Other applicant names beginning “Mueller”

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

Mueller Chemical Co. 1Mueller Water Conditioning, Inc. 1