510(k) Report

FDA applicant

Flosonics Medical (R/A 1929803 Ontario Corp.)

Toronto, CA2 decisions2019–20201 recall

FDA records 2 decisions for Flosonics Medical (R/A 1929803 Ontario Corp.) (Toronto, CA) from 2019 to 2020: 2 510(k) clearances. All are in product code DPW (Flowmeter, Blood, Cardiovascular). Its devices cite 2 predicates, 0 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 (R/A 1929803 Ontario Corp.)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2019: 12020: 1
2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2019high 1 (2025) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Flosonics Medical (R/A 1929803 Ontario Corp.) by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Flosonics Medical (R/A 1929803 Ontario…’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?

  • DPWFlowmeter, Blood, Cardiovascular2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K200337FloPatch (FP120)Flosonics Medical (R/A 1929803 Ontario Corp.) · 20201cites it
  • K191388FloPatch (FP110)Flosonics Medical (R/A 1929803 Ontario Corp.) · 20191cites it

What has FDA decided for it lately?

  • K200337FloPatch (FP120)Flosonics Medical (R/A 1929803 Ontario Corp.) · 20201 recall
  • K191388FloPatch (FP110)Flosonics Medical (R/A 1929803 Ontario Corp.) · 2019

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

What has been recalled?

1 recall linked to its devices; the latest:

  • K200337FloPatch FP120, REF: FP120-FOT01-005Aug 7, 2025Class III

Other applicant names beginning “Flosonics”

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

Flosonics Medical 4