# K051262: Esprit Ventilator Neonatal Option, Model V1000

- Pathway: 510(k) (Traditional)
- Applicant: Respironics California, Inc.
- Decided: Jul 8, 2005 after 53 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K902859 (1991). 15 ancestors in all.
No later device cites it as a predicate yet.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001646: Puritan-Bennett 840 Ventilator System with Neomode Option, Puritan Bennett Corp. (2000) Summary page 1.
- K021112: Inspiration Ventilator System, eVent Medical, Ltd. (2002) Summary page 1.
- K970839: Servo Ventilator 300A, Siemens Elema AB (1997) Summary page 1.
- K983219: Neoflow Option Model Numbers 8413563, 8411900, Drager, Inc. (1998) Summary page 1.

## Recalls of this device
- 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

## Indications for use
The intended use of the Esprit Ventilator Neonatal Option is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes intubated neonatal patients with an ideal body weight range from 0.5 kg to 6.5 kg and an endotracheal tube I.D. range from 2.5 - 4.0 mm.

Source page: https://510kreport.com/device/K051262
Methodology: https://510kreport.com/methodology