510(k) Report

FDA applicant

O-Two Medical Technologies, Inc.

Mississauga, CA8 decisions2005–20185 recalls

FDA records 8 decisions for O-Two Medical Technologies, Inc. (Mississauga, CA) from 2005 to 2018: 8 510(k) clearances. Most are in product codes BTL (Ventilator, Emergency, Powered (Resuscitator)) and BZR (Mixer, Breathing Gases, Anesthesia Inhalation). Its devices cite 12 predicates, 4 of them its own earlier devices. 5 recalls are linked to its devices, 3 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 O-Two Medical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2009: 12010: 12011: 12012: 12015: 12018: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2019

2018: 22019: 3, 3 Class I
2007high 3 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like O-Two Medical Technologies, 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)5decisions
  • BZRMixer, Breathing Gases, Anesthesia Inhalation2decisions
  • BYEAttachment, Breathing, Positive End Expiratory Pressure1decision

Whose devices does it build on?

Its devices cite 12 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 4 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.

  • K051469Carevent Atv+ and Carevent MriO-Two Medical Technologies, Inc. · 20052cite it
  • K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 20151cites it
  • K113687Equinox RelieveO-Two Medical Technologies, Inc. · 20121cites it
  • K093862Carevent Handheld Cpap SystemO-Two Medical Technologies, Inc. · 20101cites it
  • K081330Carevent Par (Public Access Resuscitator)O-Two Medical Technologies, Inc. · 20091cites it

What has FDA decided for it lately?

  • K173205Equinox AdvantageO-Two Medical Technologies, Inc. · 2018
  • K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 20153 Class I recalls
  • K113687Equinox RelieveO-Two Medical Technologies, Inc. · 20122 recalls
  • K112546O_Two Cpap SystemO-Two Medical Technologies, Inc. · 2011
  • K093862Carevent Handheld Cpap SystemO-Two Medical Technologies, Inc. · 2010
  • K081330Carevent Par (Public Access Resuscitator)O-Two Medical Technologies, Inc. · 2009
  • K051469Carevent Atv+ and Carevent MriO-Two Medical Technologies, Inc. · 2005
  • K051889Carevent CA and DraO-Two Medical Technologies, Inc. · 2005

All 8 as O-Two Medical Technologies, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K141595e500 Automatic Transport Ventilator, Model Number 01EVE500Feb 12, 2019Class I
  • K141595e700 Automatic Transport Ventilator, Model Number 01EVE700Feb 12, 2019Class I
  • K141595e600 Automatic Transport Ventilator, Model Number 01EVE600Feb 12, 2019Class I
  • K113687CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100…May 15, 2018Class II
  • K113687O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000May 14, 2018Class II