# K090888: Newport HT70 Family of Ventilators

- Pathway: 510(k) (Traditional)
- Applicant: Newport Medical Instruments, Inc.
- Decided: Nov 18, 2009 after 232 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 4 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K902859 (1991). 82 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K992133: Newport HT50 Ventilator with Humidifier HT50-H, Newport HT50 Ventilator Without Humidifier, HT50-H1, Newport HT50 Ventil, Newport Medical Instruments, Inc. (2000) Summary page 1.
- K082724: Newport HTS50 Ventilator with Dual Pac Battery System, Newport Medical Instruments, Inc. (2008) Summary page 1.
- K981371: LTV 1000 Ventilator, Pulmonetic Systems, Inc. (1998) Summary page 1.
- K984056: LTV 1000, Pulmonetic Systems, Inc. (1999) Summary page 1.
- K002881: Ventilator, Continuous (Respirator), Model LTV 1000, Pulmonetic Systems, Inc. (2000) Summary page 1.
- K010608: Modification to Lap Top Ventilator (LTV), Pulmonetic Systems, Inc. (2001) Summary page 1.
- K032226: LTV-1000 Ventilator, Pulmonetic Systems, Inc. (2003) Summary page 1.
- K040540: Modification to LTV 1000 Ventilator, Pulmonetic Systems, Inc. (2004) Summary page 1.
- K051767: LTV 1000 Ventilator, Pulmonetic Systems, Inc. (2005) Summary page 1.
- K070594: Palmtop Ventilator, Models PTV-8, PTV-10, Pulmonetic Systems, Inc. (2007) Summary page 1.
- K981668: Smartvent 201 Portable Ventilator, Versamed, Ltd. (1999) Summary page 1.
- K011957: Ivent 201 Portable Ventilator, Versamed, Ltd. (2001) Summary page 1.
- K021981: Ivent 201 Portable Ventilator, Versamed, Ltd. (2003) Summary page 1.
- K042468: Ivent 201 Portable Ventilator, Versamed Medical Systems, Inc. (2004) Summary page 1.
- K052554: Modification to: Ivent 201 Portable Ventilator, Versamed Medical Systems, Inc. (2005) Summary page 1.
- K053270: IVENT 201, Versamed Medical Systems, Inc. (2006) Summary page 1.
- K061627: Modification to I Vent 201, Versamed Medical Systems, Inc. (2006) Summary page 1.
- K073694: Ivent 2001 Mri Conditional, Versamed Medical Systems, Inc. (2008) Summary page 1.

## Most influential descendants
- K111146: Newport HT70 Ventilator (2011), 1 descendant of its own
- K121891: Newport Aura Ventilator (2012), 0 descendants of its own

## Recalls of this device
- 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.
- Sep 20, 2010 · Not classified · Z-2406-2011: The recall was initiated because Newport Medical has confirmed a limited number of power cords recently received from their supplier, Glob-Tek, have a slightly oversized plug connector which prevents 

## 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 lbs). 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/K090888
Methodology: https://510kreport.com/methodology