# K082724: Newport HTS50 Ventilator with Dual Pac Battery System

- Pathway: 510(k) (Traditional)
- Applicant: Newport Medical Instruments, Inc.
- Decided: Dec 16, 2008 after 90 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K902859 (1991). 61 ancestors in all.
9 later devices descend from it; 2 cite it directly.
6 of 71 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.
- 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.
- 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.

## Most influential descendants
- K100753: Flight 60 Ventilator, Model F-60 (2010), 5 descendants of its own
- K111683: Flight 60 Ventilator (2011), 4 descendants of its own
- K120726: Flight 60 Ventilator (2012), 3 descendants of its own
- K130171: Flight 60 Ventilator (2014), 2 descendants of its own
- K090888: Newport HT70 Family of Ventilators (2009), 2 descendants of its own

## Recalls of this device
- Aug 10, 2011 · Not classified · Z-1041-2012: The recall was initiated because Flight Medical Innovations Ltd. has identified a problem may occur when contact between an exposed unused wire and the grounding wire occurs. If this contact occurs th
- Jul 22, 2009 · Not classified · Z-2384-2011: The recall was initiated because Newport Medical has confirmed that the HT50 Dual Pac Ventilator is not compatiable with the external battery pack (p/n BAT3300A) supplied with the previous single batt

## Indications for use
The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 lbs), who require the following general types of ventilatory support: positive pressure ventilation with Assist/Control, SIMV and SPONT/CPAP modes of ventilation. The NEWPORT HT50 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it 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/K082724
Methodology: https://510kreport.com/methodology