# K101643: Model LTV 1100 Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Jan 26, 2011 after 230 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: 8 generations back to K902859 (1991). 51 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060647: LTV 1200 Ventilator, Pulmonetic Systems, Inc. (2006) Summary page 1.
- K093094: Vela Ventilator, Cardinal Health 207, Inc. (2010) Summary page 1.
- K981371: LTV 1000 Ventilator, Pulmonetic Systems, Inc. (1998) Summary page 1.

## Most influential descendants
- K201082: LTV2 Series Ventilators (2021), 0 descendants of its own

## Indications for use
The LW® 1100 ventilator is intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation. The ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator isapplicable for adult and pediatric patients weighing at least 5kg (11 lbs.), who require the following types of ventilatory support: Positive Pressure Ventilation, delivered invasively (via endlotrach tube or trach tube) or non-invasively (via mask or nasal prongs). Assist/Control, SIMV, CPAP, and NPPV modes of ventilation. The ventilator issuitable for use in institutional, home, or transport settings.

Source page: https://510kreport.com/device/K101643
Methodology: https://510kreport.com/methodology