# K062793: Servo-I Ventilator System, Model 64 87 800 E407E; Nava Option

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Critical Care AB
- Decided: Feb 7, 2007 after 142 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: 8 generations back to K902859 (1991). 49 ancestors in all.
No later device cites it as a predicate yet.
5 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061090: Galileo Gold Asv, Hamilton Medical AG (2006) Summary page 1.
- K053388: Model 840 Ventilator with Proportional Assist Ventilation Plus Software Option, Puritan Bennett Corp. (2006) Summary page 1.
- K051263: Evitaxl with Option Smartcare, Drager Medical AG & Co. Kgaa (2005) Summary page 1.
- K040221: Servo-I Ventilator System, Model 64 87 800 E407E, Maquet Critical Care AB (2004) Summary page 1.
- K013642: AVEA, Bird Products Corp. (2002) Summary page 1.
- K942852: Respitrace PT, Non-Invasive Monitoring Systems, Inc. (1996) Summary page 2.
- K935788: Bicore Smartcath Intratracheal Catheter, Bicore Monitoring Systems (1995) Summary page 2.
- K920121: Sechrist IV-100B Savi System, Sechrist (1993) Summary page 2.
- K923704: Infant Star Series 500, Infrasonics Corp. (1992) Summary page 2.
- K903136: Arzo Tapcath Esophageal Recording Catheter, Arzco Medical Electronics, Inc. (1991) Summary page 2.
- K905831: Arzco Octapolar Esophageal Cardiac Record Cath, Arzco Medical Electronics, Inc. (1991) Summary page 2.
- K925854: Vygon - Enteral Feeding Tube - Polyurethane, Vygon Corp. (1994) Summary page 2.
- K940870: Umbili-Cath, Gesco Intl., Inc. (1994) Summary page 2.

## Indications for use
The Servo-i ventilator with NAVA option is intended for treatment and monitoring to improve synchrony between the ventilator and patients. The Servo-i with NAVA option is suitable for patient ranges of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo-i is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport. The added indications for use of the NAVA option is when the electrical signal from the brain to the diaphragm is intact; NAVA will improve synchrony between the ventilator and patients with no contraindication for insertion/exchange of a Naso Gastric tube.

Source page: https://510kreport.com/device/K062793
Methodology: https://510kreport.com/methodology