510(k) Report

FDA applicant

Wheaton Franciscan Services Inc., Supply Chain

Salt Lake City, UT1 decision2004–20040 recalls

FDA records 1 decision for Wheaton Franciscan Services Inc., Supply Chain (Salt Lake City, UT) in 2004: 1 510(k) clearance. All are in product code JOW (Sleeve, Limb, Compressible). Its devices cite 1 predicate, 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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Wheaton Franciscan Services Inc., Supply Chain’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wheaton Franciscan Services Inc., Supply Chain since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wheaton Franciscan Services Inc., Supply Chain by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JOWSleeve, Limb, Compressible1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K033615Wfsi's Reprocessed Compression Sleeve DevicesWheaton Franciscan Services Inc., Supply Chain · 2004

The one decision as Wheaton Franciscan Services Inc., Supply Chain →