# K981072: Esprit Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Nov 12, 1998 after 233 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 11 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
145 later devices descend from it; 10 cite it directly.
45 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 7200 ventilator: named in the summary without a submission number
- (no number) BIRD Tbird: named in the summary without a submission number
- (no number) Siemens SY300: named in the summary without a submission number

## Most influential descendants
- K032451: Bird Tbird Vela Ventilator (2004), 114 descendants of its own
- K052554: Modification to: Ivent 201 Portable Ventilator (2005), 112 descendants of its own
- K053270: IVENT 201 (2006), 87 descendants of its own
- K061627: Modification to I Vent 201 (2006), 86 descendants of its own
- K063404: Servo-I Ventilator System, Models 64, 87 and 800 (2007), 61 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
- Apr 22, 2009 · Not classified · Z-1813-2009: The recall was initiated because through routine product monitoring Respironics discovered that under certain conditions, when operating on AC line power, a portion of the current from the External Ba
- 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.
- Aug 8, 2006 · Not classified · Z-0047-2007: This action is being initiated due to power supply snubber board failures on certain Esprit Ventilators in countries that utilize operating voltages of 200-240 Volts AC and will involve the replacemen
- Feb 20, 2002 · Not classified · Z-1230-04: Flow sensors would exhibit drift.
- Jun 8, 2001 · Not classified · Z-0951-03: Material hardness on original design check valve may cause premature failure.
- Jun 1, 2001 · Not classified · Z-0903-04: Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue.

## 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/K981072
Methodology: https://510kreport.com/methodology