510(k) Report

FDA applicant

Breathe Technologies, Inc.

Alameda, CA8 decisions2009–201713 recalls

FDA records 8 decisions for Breathe Technologies, Inc. (Alameda, CA) from 2009 to 2017: 8 510(k) clearances. Most are in product codes ONZ (Mechanical Ventilator) and CBK (Ventilator, Continuous, Facility Use). Its devices cite 10 predicates, 5 of them its own earlier devices. 13 recalls are linked to its devices, 12 Class I.

FDA’s records also spell it “Breathe Technologies”.

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 Breathe Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2009: 12010: 22011: 12013: 12014: 12015: 12017: 1
2009high 2 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

2in 2025

2020: 12023: 4, 4 Class I2024: 6, 6 Class I2025: 2, 2 Class I
2009high 6 (2024) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Breathe Technologies, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Breathe 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?

  • ONZMechanical Ventilator5decisions
  • CBKVentilator, Continuous, Facility Use2decisions
  • BZDVentilator, Non-Continuous (Respirator)1decision

Whose devices does it build on?

Its devices cite 10 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 5 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.

  • K131562Breathe Niov Ventilation SystemBreathe Technologies · 20141cites it
  • K102525Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc. · 20101cites it
  • K082982Breathe Technologies Ventilator and AccessoriesBreathe Technologies, Inc. · 20091cites it
  • K103345Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc. · 20111cites it
  • K141943Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies · 20151cites it
  • K100528Breathe Technologies Ventilator and Accessories BT-V2SBreathe Technologies, Inc. · 20101cites it

What has FDA decided for it lately?

  • K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies · 201712 Class I recalls
  • K141943Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies · 2015
  • K131562Breathe Niov Ventilation SystemBreathe Technologies · 2014
  • K130037Breathe Cpap SystemBreathe Technologies, Inc. · 2013
  • K103345Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc. · 2011
  • K102525Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc. · 2010
  • K100528Breathe Technologies Ventilator and Accessories BT-V2SBreathe Technologies, Inc. · 2010
  • K082982Breathe Technologies Ventilator and AccessoriesBreathe Technologies, Inc. · 2009

All 5 as Breathe Technologies, Inc. →All 3 as Breathe Technologies →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K170037Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A…Apr 7, 2025Class I
  • K170037Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3)…Apr 7, 2025Class I
  • K170037Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002APDec 20, 2024Class I
  • K170037Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002Dec 20, 2024Class I
  • K170037Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002ADec 20, 2024Class I
  • K170037Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002APDec 20, 2024Class I

Other applicant names beginning “Breathe”

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

Breathe Me, Ltd. 1Breathe With Eez Corp. 1