# K141943: Breathe Technologies LIFE2000 Ventilation System

- Pathway: 510(k) (Traditional)
- Applicant: Breathe Technologies
- Decided: Jun 12, 2015 after 330 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- 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). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060647: LTV 1200 Ventilator, Pulmonetic Systems, Inc. (2006) Summary page 4.

## Most influential descendants
- K170037: Breathe Technologies Life2000™ Ventilation System (2017), 0 descendants of its own

## Indications for use
The Breathe Technologies Life2000 Ventilation System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult patients who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). - Assist/Control mode of ventilation. The ventilator is suitable for use in home and institutional settings.

Source page: https://510kreport.com/device/K141943
Methodology: https://510kreport.com/methodology