# K040790: Modification to LTV 1000 Ventilator/Breathing Circuits

- Pathway: 510(k) (Special)
- Applicant: Pulmonetic Systems, Inc.
- Decided: Jun 3, 2004 after 66 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: 2 generations back to K950484 (1996). 3 ancestors in all.
44 later devices descend from it; 2 cite it directly.
17 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981371: LTV 1000 Ventilator, Pulmonetic Systems, Inc. (1998) Summary page 2.
- K000697: Modification to Airlife Heated Ventilator and Anesthesia Breathing Circuits, Allegiance Healthcare Corp. (2000) Summary page 1.

## Most influential descendants
- K060705: Carina Home (2006), 22 descendants of its own
- K103167: Stellar 150 (2011), 20 descendants of its own
- K062267: Oxylog 3000 (2006), 20 descendants of its own
- K112006: Hamilton-TC1 (2012), 13 descendants of its own
- K120670: Hamilton-T1 (2012), 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. The ventilator is suitable for use in institutional, home, or transport settings.

Source page: https://510kreport.com/device/K040790
Methodology: https://510kreport.com/methodology