Breathe Technologies Life2000 Ventilation System— 510(k) K170037

Clearance details

Applicant

Breathe Technologies

Product code

Code CBK

Device class

Class 2

Regulation

21 CFR 868.5895

Advisory panel

Anesthesiology

Date received

2017-01-04

Decision date

2017-08-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irvine, CA, US

• K253647 — Evita (V800); Evita (V600)2026-05-07
• K252663 — Inbentus Versatile2026-04-14
• K251888 — VPAP Pediatric Face Mask2026-03-12
• K232365 — Vivo 45 LS2025-12-19
• K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A) +3 more2025-09-10

• K141943 — BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM2015-06-12
• K131562 — BREATHE NIOV VENTILATION SYSTEM2014-03-06

Death

736

Injury

3,628

Malfunction

98,786

Other

4

Total

103,154

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1725-2025 — Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.Class I·Ongoing·Baxter Healthcare Corporation·20250407
• Z-1726-2025 — Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.Class I·Ongoing·Baxter Healthcare Corporation·20250407
• Z-0884-2025 — Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002Class I·Ongoing·Baxter Healthcare Corporation·20241220
• Z-0885-2025 — Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AClass I·Ongoing·Baxter Healthcare Corporation·20241220
• Z-0886-2025 — Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002APClass I·Ongoing·Baxter Healthcare Corporation·20241220
• Z-0887-2025 — Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002APClass I·Ongoing·Baxter Healthcare Corporation·20241220
• Z-0046-2025 — Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CPClass I·Ongoing·Baxter Healthcare Corporation·20240912
• Z-2140-2024 — Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.Class I·Ongoing·Baxter Healthcare Corporation·20240529
• Z-1139-2023 — Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individualsClass I·Ongoing·Baxter Healthcare Corporation·20230125
• Z-1140-2023 — Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individualsClass I·Ongoing·Baxter Healthcare Corporation·20230125
• Z-1141-2023 — Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individualsClass I·Ongoing·Baxter Healthcare Corporation·20230125
• Z-1142-2023 — Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individualsClass I·Ongoing·Baxter Healthcare Corporation·20230125
• Z-0484-2021 — Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air transport.Class II·Terminated·Hill-Rom Manufacturing, Inc.·20201112

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170037.