# K103345: Breathe Technologies Ventilator and Accessories (BT-V2S)

- Pathway: 510(k) (Traditional)
- Applicant: Breathe Technologies, Inc.
- Decided: Feb 11, 2011 after 88 days
- Product code: ONZ (Mechanical Ventilator)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K902859 (1991). 21 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102525: Breathe Technologies Ventilator and Accessories (BT-V2S), Breathe Technologies, Inc. (2010). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K131562: Breathe Niov Ventilation System (2014), 1 descendant of its own
- K152664: TAV System (2016), 0 descendants of its own

## Indications for use
The Breathe TechnologiesTM Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients, or caregivers under the direction of a physician.

Source page: https://510kreport.com/device/K103345
Methodology: https://510kreport.com/methodology