FDA applicant

Smiths Medical International Ltd., Luton

Waukesha, WI1 decision2005–20050 recalls

FDA records 1 decision for Smiths Medical International Ltd., Luton (Waukesha, WI) in 2005: 1 510(k) clearance. All are in product code BTL (Ventilator, Emergency, Powered (Resuscitator)). 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

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

How often FDA has decided Smiths Medical International Ltd., Luton’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Smiths Medical International Ltd., Luton since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Smiths Medical International Ltd., Luton 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 Pm, Inc. 5 Smiths Medical International, Ltd. 4 Smiths Medical 3 Smiths Medical Ads, Inc. 2

Smiths Medical International Ltd., Luton

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”