FDA applicant

Tso3, Inc.

Quebec, CA10 decisions2006–20190 recalls

FDA records 10 decisions for Tso3, Inc. (Quebec, CA) from 2006 to 2019: 10 510(k) clearances. Most are in product codes PJJ (Two Or More Sterilant Sterilizer) and FLF (Sterilizer, Ethylene-Oxide Gas). Its devices cite 16 predicates, 5 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, general hospital panel, where it files most

How often FDA has decided Tso3, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007high 3 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tso3, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tso3, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Tso3”

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

Tso3 Inc., Now A Part of Stryker 1

Tso3, 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 “Tso3”