# K051767: LTV 1000 Ventilator

- Pathway: 510(k) (Special)
- Applicant: Pulmonetic Systems, Inc.
- Decided: Jul 29, 2005 after 29 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K902859 (1991). 13 ancestors in all.
57 later devices descend from it; 6 cite it directly.
20 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032226: LTV-1000 Ventilator, Pulmonetic Systems, Inc. (2003) Summary page 2.
- K041775: GE Datex-Ohmeda Engstrom Carestation, Datex-Ohmeda, Inc. (2004) Summary page 2.

## Most influential descendants
- K060647: LTV 1200 Ventilator (2006), 29 descendants of its own
- K083526: Trilogy 100 Ventilator (2009), 26 descendants of its own
- K093416: Trilogy 200 Ventilator (2010), 19 descendants of its own
- K070594: Palmtop Ventilator, Models PTV-8, PTV-10 (2007), 12 descendants of its own
- K111610: Trilogy Series Ventilator with Oximetry (2011), 11 descendants of its own

## Indications for use
The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory 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 weighing at least 5 kg (11 lbs), who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). - Assist/Control, SIMV, or CPAP modes of ventilation. - Breath types including Volume, Pressure Control and Pressure Support. The ventilator is suitable for use in institutional, home, or transport settings.

Source page: https://510kreport.com/device/K051767
Methodology: https://510kreport.com/methodology