# K992133: Newport HT50 Ventilator with Humidifier HT50-H, Newport HT50 Ventilator Without Humidifier, HT50-H1, Newport HT50 Ventil

- Pathway: 510(k) (Traditional)
- Applicant: Newport Medical Instruments, Inc.
- Decided: Aug 4, 2000 after 408 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
33 later devices descend from it; 4 cite it directly.
13 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TBird Legacy Ventilator: named in the summary without a submission number
- (no number) Pulmonetics LTV1000 ventilator: named in the summary without a submission number

## Most influential descendants
- K083526: Trilogy 100 Ventilator (2009), 26 descendants of its own
- K093416: Trilogy 200 Ventilator (2010), 19 descendants of its own
- K111610: Trilogy Series Ventilator with Oximetry (2011), 11 descendants of its own
- K133868: Astral Ventilator (2014), 10 descendants of its own
- K112754: IVENT101 (2012), 9 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
- May 14, 2010 · Not classified · Z-2382-2011: The recall was initiated because Newport Medical has confirmed that the Newport HT50 hard shell Emergency Preparedness (EP) Storage Cases must be relabeled to caution users to follow current labeling 
- Jan 13, 2009 · Not classified · Z-2295-2011: The recall was initiated because Newport Medical Instruments confirmed that the Newport HT50 ventilators that were shipped in December 2008 were without the label on the top of the ventilator that rem
- Jul 31, 2007 · Not classified · Z-1192-2007: Battery Life: With use over time, the internal battery begins losing its ability to hold a charge resulting in shortened ventilator operation time. Specifically, Newport has received a number of repor
- Oct 29, 2005 · Not classified · Z-1375-05: Lack of alarm prior to shutdown.

## Indications for use
The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients, greater than 10 kg or 22 lbs., who require the following general types of ventilatory support, as prescribed by an attending physician: positive pressure ventilation and assist/control. SIMV, CPAP modes of ventilation. The ventilator is suitable for use in post-acute, emergency room, home care environments (P/N HT50-H) and for transport applications (P/N HT50-T). Transport application is only applicable to the HT50-T.

Source page: https://510kreport.com/device/K992133
Methodology: https://510kreport.com/methodology