# K102054: V200 Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Respironics California, Inc.
- Decided: Dec 22, 2010 after 153 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: 1 generation back to K981072 (1998). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981072: Esprit Ventilator, Respironics, Inc. (1998) Summary page 1.

## Most influential descendants
- K110083: V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv Mode (2012), 0 descendants of its own
- K110795: V200 Intelli-Trak Option (2011), 0 descendants of its own

## Indications for use
The V200 Ventilator is a microprocessor 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 and contains the following modes of ventilation: * Assist/Control (A/C) * Synchronized Intermittent Mandatory Ventilation (SIMV) " Continuous Positive Airway Pressure (CPAP) * Spontaneous (Spont) * Spontaneous/Timed (SpontlT) * Apnea (Backup Mode)

Source page: https://510kreport.com/device/K102054
Methodology: https://510kreport.com/methodology