Breathe Technologies, Inc.
Breathe Technologies, Inc. has 0 FDA recalls, 1 inspection, 8 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Sep 22, 2014 · NAI
- Latest 510(k)
- Aug 11, 2017
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 8 | Oct 4, 2026 | Not stated | Current |
| Inspections | 1 | Oct 25, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 22, 2014 | Irvine, CA | Devices | No Action Indicated (NAI) | 3008778542 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K170037 | Breathe Technologies Life2000 Ventilation System | Aug 11, 2017 |
| K141943 | BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM | Jun 12, 2015 |
| K131562 | BREATHE NIOV VENTILATION SYSTEM | Mar 6, 2014 |
| K130037 | BREATHE CPAP SYSTEM | May 17, 2013 |
| K103345 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | Feb 11, 2011 |
| K102525 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | Dec 2, 2010 |
| K100528 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S | Apr 23, 2010 |
| K082982 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES | Jul 20, 2009 |