NEWPORT HT70 VENTILATOR
FDA 510(k) clearance K111146 · decided 2011-12-01
Clearance details
- K-number
- K111146
- Device name
- NEWPORT HT70 VENTILATOR
- Applicant
- Newport Medical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-22
- Decision date
- 2011-12-01
- Days to decision
- 223 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Costa Mesa, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY recall (Z-1915-2025) | Covidien | 2025-06-09 |
| Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 f recall (Z-1874-2017) | Newport Medical Instruments Inc | 2017-04-10 |
| Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: T recall (Z-2250-2012) | Newport Medical Instruments Inc | 2014-04-14 |
| Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number recall (Z-1171-2013) | Newport Medical Instruments Inc | 2013-04-26 |