FDA applicant

Trudell Medical International

London, CA9 decisions2015–20251 recall

FDA records 9 decisions for Trudell Medical International (London, CA) from 2015 to 2025: 9 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and BWF (Spirometer, Therapeutic (Incentive)). Since 2016 its 510(k)s took a median of 186 days from receipt to decision, against 219 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 4 of them its own earlier devices. 1 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 Trudell Medical International’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2015high 3 (2018) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2021

2015high 1 (2021) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Trudell Medical International by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Trudell”

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

Trudell Medical Intl. 12 Trudell Medical Int'L 3 Trudell Medical 3

Trudell Medical International

Which product codes does it file in?

How long do its 510(k) reviews take?

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?

What has been recalled?

Other applicant names beginning “Trudell”