# K110795: V200 Intelli-Trak Option

- Pathway: 510(k) (Traditional)
- Applicant: Respironics California, Inc.
- Decided: Aug 19, 2011 after 150 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 K981072 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102054: V200 Ventilator, Respironics California, Inc. (2010) Summary page 1.

## Indications for use
The V200 Ventilator is a microp~rocessor-controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients as prescribed by a physician. The V200 Ventilator is intended for use in either invasive or non-invasive applications. The IntelliTrak option provides new triggering and fuinctionality that is intended for use only with adult and pediatric patients in invasive applications.

Source page: https://510kreport.com/device/K110795
Methodology: https://510kreport.com/methodology