# K071212: Esprit Ventilator Speaking Mode Option, Model V1000

- Pathway: 510(k) (Traditional)
- Applicant: Respironics California, Inc.
- Decided: Jul 30, 2007 after 90 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981072 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981072: Esprit Ventilator, Respironics, Inc. (1998) Summary page 1.

## Indications for use
The ESPRIT ventilatory 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, pediatric and neonatal patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or non-invasive applications. The Speaking Mode software option allows tracheostomized adult and pediatric patients who meet the assessment criteria to vocalize without the need of a speaking valve.

Source page: https://510kreport.com/device/K071212
Methodology: https://510kreport.com/methodology