510(k) Report

FDA applicant

Thornhill Research, Inc.

Toronto, CA5 decisions2010–20192 recalls

FDA records 5 decisions for Thornhill Research, Inc. (Toronto, CA) from 2010 to 2019: 4 510(k) clearances and 1 De Novo grant. Most are in product codes BTL (Ventilator, Emergency, Powered (Resuscitator)) and QFB (Isocapnic Ventilation Device). Its devices cite 19 predicates, 2 of them its own earlier devices. 2 recalls are linked to its devices, 2 Class I.

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 Thornhill Research, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2010: 12014: 12015: 12017: 12019: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

2in 2015

2015: 2, 2 Class I
2010high 2 (2015) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Thornhill Research, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Thornhill Research, 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?

  • BTLVentilator, Emergency, Powered (Resuscitator)3decisions
  • QFBIsocapnic Ventilation Device1decision
  • BSZGas-Machine, Anesthesia1decision

Whose devices does it build on?

Its devices cite 19 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K093261MOVESThornhill Research, Inc. · 20102cite it
  • K140049Moves SLCThornhill Research, Inc. · 20141cites it

What has FDA decided for it lately?

  • DEN170044ClearMateThornhill Research, Inc. · 2019
  • K161420Moves SLCThornhill Research, Inc. · 2017
  • K140264MADMThornhill Research, Inc. · 2015
  • K140049Moves SLCThornhill Research, Inc. · 2014
  • K093261MOVESThornhill Research, Inc. · 20102 Class I recalls

All 5 as Thornhill Research, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K093261MOVES System, an emergency ventilator with suction, oxygen concentrator and…Nov 19, 2015Class I
  • K093261MOVES System Lithium Polymer Batteries The MOVES System is a portable computer…Nov 19, 2015Class I