# K023350: Esprit Ventilator with Respiratory Mechanics

- Pathway: 510(k) (Traditional)
- Applicant: Respironics California, Inc.
- Decided: Nov 6, 2002 after 30 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 7 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K833786 (1983). 16 ancestors in all.
2 later devices descend from it; 2 cite it directly.
3 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902506: 7200AE Microprocessor Ventilator W/Enhanced Hard., Puritan Bennett Corp. (1991) Summary page 1.
- K970460: Nellcor Puritan Bennett, 840 Ventilator System (Model 840), Puritan Bennett Corp. (1998) Summary page 1.
- K905272: Adult Star, Modification, Infrasonics Corp. (1991) Summary page 1.
- K961687: EVITA 4, Drager, Inc. (1996) Summary page 1.
- K982454: Bipap Vision Ventilatory Support, Respironics, Inc. (1998) Summary page 1.

## Most influential descendants
- K034040: Esprit Ventilator, Model V1000 (2004), 1 descendant of its own
- K041412: Esprit Ventilator with Nico-Esprit Interface Option, Model V1000 (2004), 0 descendants of its own

## Recalls of this device
- Oct 29, 2014 · Class II · Z-0485-2015: If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ven
- Sep 17, 2014 · Class I · Z-0008-2015: A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is de
- Jan 25, 2008 · Not classified · Z-2002-2008: This action is being taken to address power supply failures on the Esprit Ventilator which have occurred in some units. These failures, which were discovered through routine product monitoring, have b
- Jan 25, 2008 · Not classified · Z-2003-2008: This action is being taken to address power supply failures on the Esprit Ventilator which have occurred in some units. These failures, which were discovered through routine product monitoring, have b
- Jan 25, 2008 · Not classified · Z-2004-2008: This action is being taken to address power supply failures on the Esprit Ventilator which have occurred in some units. These failures, which were discovered through routine product monitoring, have b
- Oct 29, 2007 · Class II · Z-2084-2013: The power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark and making the display unreadable.
- Feb 20, 2002 · Not classified · Z-1230-04: Flow sensors would exhibit drift.

## 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 and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.

Source page: https://510kreport.com/device/K023350
Methodology: https://510kreport.com/methodology