510(k) K170037 · CBK Ventilator, Continuous, Facility Use
Breathe Technologies Life2000 Ventilation System
| Applicant | Breathe Technologies, Irvine CA, US |
| Decision | Substantially Equivalent, Aug 11, 2017 |
| Received | Jan 4, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170037
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2025 | Baxter Healthcare Corporation 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. Open, Classified |
CBK | None listed |
| May 9, 2025 | Baxter Healthcare Corporation Welch Allyn Life2000 Compressor, Product Codes:
1) BT-80-0004;
2) BT-80-0004A;
3) BT-80-0008;
4) BT-80-0008A;
5) RMS010093CP. Open, Classified |
CBK | None listed |
| Jan 16, 2025 | Baxter Healthcare Corporation Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002 Open, Classified |
CBK | None listed |
| Jan 16, 2025 | Baxter Healthcare Corporation Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A Open, Classified |
CBK | None listed |
| Jan 16, 2025 | Baxter Healthcare Corporation Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP Open, Classified |
CBK | None listed |
| Jan 16, 2025 | Baxter Healthcare Corporation Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP Open, Classified |
CBK | None listed |
| Oct 22, 2024 | Baxter Healthcare Corporation 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) RMS010118CP Open, Classified |
CBK | None listed |
| Jun 26, 2024 | Baxter Healthcare Corporation 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 in Open, Classified |
CBK | None listed |
| Feb 24, 2023 | Baxter Healthcare Corporation Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals Open, Classified |
CBK | None listed |
| Feb 24, 2023 | Baxter Healthcare Corporation Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals Open, Classified |
CBK | None listed |
| Feb 24, 2023 | Baxter Healthcare Corporation Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals Open, Classified |
CBK | None listed |
| Feb 24, 2023 | Baxter Healthcare Corporation Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals Open, Classified |
CBK | None listed |
| Nov 12, 2020 | Hill-Rom Manufacturing, Inc. 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 tr Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.