FDA applicant

Smiths Medical Pm, Inc.

Waukesha, WI5 decisions2007–20090 recalls

FDA records 5 decisions for Smiths Medical Pm, Inc. (Waukesha, WI) from 2007 to 2009: 5 510(k) clearances. All are in product code DQA (Oximeter). Its devices cite 10 predicates, 3 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 Smiths Medical Pm, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2009

2007high 4 (2009) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Smiths Medical Pm, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Smiths”

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

Smiths Medical Asd, Inc. 53 Smiths Industries Medical Systems, Inc. 23 Smiths Medical MD, Inc. 20 Smiths Medical International, Ltd. 4 Smiths Medical 3 Smiths Medical Ads, Inc. 2 Smiths Medical International Ltd., Luton 1

Smiths Medical Pm, Inc.

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 “Smiths”