# K001208: Espirt

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: May 12, 2000 after 28 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 8 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- 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
- 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.
- Feb 20, 2002 · Not classified · Z-1230-04: Flow sensors would exhibit drift.

Source page: https://510kreport.com/device/K001208
Methodology: https://510kreport.com/methodology