# K170037: Breathe Technologies Life2000™ Ventilation System

- Pathway: 510(k) (Traditional)
- Applicant: Breathe Technologies
- Decided: Aug 11, 2017 after 219 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 13 (12 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K902859 (1991). 42 ancestors in all.
No later device cites it as a predicate yet.
4 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141943: Breathe Technologies LIFE2000 Ventilation System, Breathe Technologies (2015) Summary page 4.
- K062019: Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBD, Innomed Technologies, Inc./Respcare, Inc. (2006) Summary page 5.

## Recalls of this device
- Apr 7, 2025 · Class I · Z-1725-2025: A cybersecurity vulnerability was discovered through internal testing.
- Apr 7, 2025 · Class I · Z-1726-2025: A cybersecurity vulnerability was discovered through internal testing.
- Dec 20, 2024 · Class I · Z-0886-2025: There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Dec 20, 2024 · Class I · Z-0884-2025: There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Dec 20, 2024 · Class I · Z-0885-2025: There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Dec 20, 2024 · Class I · Z-0887-2025: There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Sep 12, 2024 · Class I · Z-0046-2025: The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initia
- May 29, 2024 · Class I · Z-2140-2024: Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prev
- Jan 25, 2023 · Class I · Z-1142-2023: There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
- Jan 25, 2023 · Class I · Z-1141-2023: There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
- Jan 25, 2023 · Class I · Z-1140-2023: There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
- Jan 25, 2023 · Class I · Z-1139-2023: There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
- Nov 12, 2020 · Class II · Z-0484-2021: Under certain conditions, there is a risk for fire.

## 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 Life2000 Ventilation System consists of the Life2000 Ventilator and the Life2000 Compressor. The System is intended for use by qualified, trained personnel under the direction of a physician. Specifically, the System 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 System is suitable for use in home and institutional settings and is not intended for ambulance or air transportation.

Source page: https://510kreport.com/device/K170037
Methodology: https://510kreport.com/methodology