# K100528: Breathe Technologies Ventilator and Accessories BT-V2S

- Pathway: 510(k) (Special)
- Applicant: Breathe Technologies, Inc.
- Decided: Apr 23, 2010 after 58 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: 7 generations back to K902859 (1991). 19 ancestors in all.
4 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)
- K082982: Breathe Technologies Ventilator and Accessories, Breathe Technologies, Inc. (2009) Summary page 1.

## Most influential descendants
- K102525: Breathe Technologies Ventilator and Accessories (BT-V2S) (2010), 3 descendants of its own
- K103345: Breathe Technologies Ventilator and Accessories (BT-V2S) (2011), 2 descendants of its own
- 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 Technologies™ Ventilator BT-V2S, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients with a tracheostomy that 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 environment. The device is intended for operation by trained personnel under the direction of a physician

Source page: https://510kreport.com/device/K100528
Methodology: https://510kreport.com/methodology