510(k) Report

FDA applicant

O-Two Systems International, Inc.

Mississauga, CA1 decision2003–20030 recalls

FDA records 1 decision for O-Two Systems International, Inc. (Mississauga, CA) in 2003: 1 510(k) clearance. All are in product code BTM (Ventilator, Emergency, Manual (Resuscitator)). Its devices cite 1 predicate, 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 O-Two Systems International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like O-Two Systems International, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • BTMVentilator, Emergency, Manual (Resuscitator)1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K021328Smart Bag MOO-Two Systems International, Inc. · 20031cites it

What has FDA decided for it lately?

  • K021328Smart Bag MOO-Two Systems International, Inc. · 2003

The one decision as O-Two Systems International, Inc. →