Skip to content

Breathe Technologies Life2000™ Ventilation System

by Breathe Technologies 510(k)

Active United States

510(k) K170037

Regulatory status

as of 27 Oct 2026

Recall ongoing. 12 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK170037 Date11 Aug 2017ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

13 recalls · 12 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1725-2025 FDA Class I initiated 7 Apr 2025
    • Ongoing Z-1726-2025 FDA Class I initiated 7 Apr 2025

    A cybersecurity vulnerability was discovered through internal testing.

  • 4 recalls, same reason

    • Ongoing Z-0885-2025 FDA Class I initiated 20 Dec 2024
    • Ongoing Z-0884-2025 FDA Class I initiated 20 Dec 2024
    • Ongoing Z-0887-2025 FDA Class I initiated 20 Dec 2024
    • Ongoing Z-0886-2025 FDA Class I initiated 20 Dec 2024

    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.

    • Ongoing Z-0046-2025 FDA Class I initiated 12 Sep 2024

    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 initiating therapy.

    • Ongoing Z-2140-2024 FDA Class I initiated 29 May 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 prevents the ventilator's internal battery from charging.

  • 4 recalls, same reason

    • Ongoing Z-1139-2023 FDA Class I initiated 25 Jan 2023
    • Ongoing Z-1142-2023 FDA Class I initiated 25 Jan 2023
    • Ongoing Z-1141-2023 FDA Class I initiated 25 Jan 2023
    • Ongoing Z-1140-2023 FDA Class I initiated 25 Jan 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.

    • Terminated Z-0484-2021 FDA Class II initiated 12 Nov 2020

    Under certain conditions, there is a risk for fire.

Specification

510(k)

510(k) Number
FDA Product Code
CBK
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Breathe Technologies, Inc.

See all devices from Breathe Technologies, Inc. →