# K111146: Newport HT70 Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Newport Medical Instruments, Inc.
- Decided: Dec 1, 2011 after 223 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K902859 (1991). 83 ancestors in all.
1 later device descends from it; 1 cites it directly.
9 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090888: Newport HT70 Family of Ventilators, Newport Medical Instruments, Inc. (2009) Summary page 1.
- K060647: LTV 1200 Ventilator, Pulmonetic Systems, Inc. (2006) Summary page 1.
- K073694: Ivent 2001 Mri Conditional, Versamed Medical Systems, Inc. (2008) Summary page 1.

## Most influential descendants
- K121891: Newport Aura Ventilator (2012), 0 descendants of its own

## Recalls of this device
- May 21, 2025 · Class I · Z-1915-2025: Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate for
- Mar 30, 2017 · Class I · Z-1874-2017: Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown spontaneously during normal operation without an accompa
- Apr 5, 2013 · Class I · Z-1171-2013: Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 P
- Aug 3, 2012 · Class I · Z-2250-2012: May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board.

## Indications for use
The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 Ibs). The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

Source page: https://510kreport.com/device/K111146
Methodology: https://510kreport.com/methodology