510(k) K111146 ยท CBK Ventilator, Continuous, Facility Use
NEWPORT HT70 VENTILATOR
| Applicant | Newport Medical Instruments, Inc., Costa Mesa CA, US |
| Decision | Substantially Equivalent, Dec 1, 2011 |
| Received | Apr 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111146
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2025 | Covidien Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU.
Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70 Open, Classified |
CBK | None listed |
| Apr 10, 2017 | Newport Medical Instruments Inc Newport Medical HT70 and HT70- Plus Ventilators, Rx Only
Product Usage:
The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilat Terminated |
CBK | None listed |
| Apr 14, 2014 | Newport Medical Instruments Inc Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus.
Product Usage:
The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ven Terminated |
CBK | None listed |
| Apr 26, 2013 | Newport Medical Instruments Inc Newport Medical Instruments HT70
and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus.
The HT70 and HT70 Plus ventilator systems are intended to provide continuous or inter Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.