510(k) Report

FDA applicant

Thorasys Thoracic Medical Systems, Inc.

Montreal, CA2 decisions2017–20230 recalls

FDA records 2 decisions for Thorasys Thoracic Medical Systems, Inc. (Montreal, CA) from 2017 to 2023: 2 510(k) clearances. All are in product code PNV (Impedance Measuring Device Utilizing…). Its devices cite 2 predicates, 1 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 Thorasys Thoracic Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2017: 12023: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Thorasys Thoracic Medical Systems, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Thorasys Thoracic Medical Systems, 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

Which product codes does it file in?

  • PNVImpedance Measuring Device Utilizing Oscillation Techniques2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K170185tremoFlo C-100 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc. · 20171cites it

What has FDA decided for it lately?

  • K221024tremoflo C2 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc. · 2023
  • K170185tremoFlo C-100 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc. · 2017

All 2 as Thorasys Thoracic Medical Systems, Inc. →