FDA applicant

Flosonics Medical

Toronto, CA4 decisions2022–20261 recall

FDA records 4 decisions for Flosonics Medical (Toronto, CA) from 2022 to 2026: 4 510(k) clearances. All are in product code DPW (Flowmeter, Blood, Cardiovascular). Its devices cite 4 predicates, 3 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2025

2022high 1 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

1in 2025

2022high 1 (2025) · low 0 (2022)2026

Class I Class II/III not classified

FIG. 1 — Flosonics Medical by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Flosonics Medical’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 “Flosonics”

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

Flosonics Medical (R/A 1929803 Ontario Corp.) 2

Flosonics Medical

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Flosonics”