510(k) Report

FDA applicant

The Smithworks Company

Bellevue, WA1 decision2006–20060 recalls

FDA records 1 decision for The Smithworks Company (Bellevue, WA) in 2006: 1 510(k) clearance. All are in product code LGZ (Warmer, Thermal, Infusion Fluid). Its devices cite 6 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

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

How often FDA has decided The Smithworks Company’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Smithworks Company since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — The Smithworks Company 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?

  • LGZWarmer, Thermal, Infusion Fluid1decision

Whose devices does it build on?

Its devices cite 6 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.

  • K060851Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer and the Thermal Sac Pressure…The Smithworks Company · 20061cites it

What has FDA decided for it lately?

  • K060851Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer and the Thermal Sac Pressure…The Smithworks Company · 2006

The one decision as The Smithworks Company →