# K110083: V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv Mode

- Pathway: 510(k) (Traditional)
- Applicant: Respironics California, Inc.
- Decided: Jan 13, 2012 after 367 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: 5 generations back to K902859 (1991). 23 ancestors in all.
No later device cites it as a predicate yet.
3 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981072: Esprit Ventilator, Respironics, Inc. (1998) Summary page 1.
- K102054: V200 Ventilator, Respironics California, Inc. (2010) Summary page 1.
- K013642: AVEA, Bird Products Corp. (2002) Summary page 1.

## Indications for use
The Esprit 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 Esprit 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 (Spont/T) Apnea (Backup Mode) The Esprit Ventilator with Airway Pressure Release Ventilation (APRV) Mode is intended for use only on invasively ventilated adult and pediatric patients as prescribed by a physician. 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 (Spont/T) Apnea (Backup Mode) The V200 Ventilator with Airway Pressure Release Ventilation (APRV) Mode is intended for use only on invasively ventilated adult and pediatric patients as prescribed by a physician.

Source page: https://510kreport.com/device/K110083
Methodology: https://510kreport.com/methodology