FDA applicant

O-Two Systems Intl., Inc.

Ontario L5s 1c8, CA14 decisions1983–19990 recalls

FDA records 14 decisions for O-Two Systems Intl., Inc. (Ontario L5s 1c8, CA) from 1983 to 1999: 14 510(k) clearances. Most are in product codes BTL (Ventilator, Emergency, Powered (Resuscitator)) and CBP (Valve, Non-Rebreathing). Its devices cite 8 predicates, 8 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 O-Two Systems Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for O-Two Systems Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — O-Two Systems Intl., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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O-Two Systems Intl., Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?