# K041412: Esprit Ventilator with Nico-Esprit Interface Option, Model V1000

- Pathway: 510(k) (Special)
- Applicant: Respironics California, Inc.
- Decided: Jun 18, 2004 after 22 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962603 (1997). 40 ancestors in all.
No later device cites it as a predicate yet.
6 of 41 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.
- K001208: Espirt, Respironics, Inc. (2000) Summary page 1.
- K023350: Esprit Ventilator with Respiratory Mechanics, Respironics California, Inc. (2002) Summary page 1.
- K034040: Esprit Ventilator, Model V1000, Respironics, Inc. (2004) Summary page 1.
- K964543: Infrasonics Adult Ventilator Trending Option, Nellcor Puritan Bennett, Inc. (1997) Summary page 1.
- K030886: Nico with Mars, Model 7300, Respironics Novametrix, Inc. (2003) Summary page 1.

## 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
- 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.

## 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/K041412
Methodology: https://510kreport.com/methodology