# K061094: Newport E500 Wave Ventilator

- Pathway: 510(k) (Special)
- Applicant: Newport Medical Instruments, Inc.
- Decided: Jul 28, 2006 after 100 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: 7 generations back to K902859 (1991). 30 ancestors in all.
2 later devices descend from it; 1 cites it directly.
4 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030780: Newport E500 Wave Ventilator, Newport Medical Instruments, Inc. (2004) Summary page 2.
- K051263: Evitaxl with Option Smartcare, Drager Medical AG & Co. Kgaa (2005) Summary page 2.
- K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E, Maquet Critical Care AB (2004) Summary page 2.
- K984535: Puritan-Bennett 840 Ventilatory System with Bilevel Option, Puritan Bennett Corp. (1998) Summary page 2.

## Most influential descendants
- K101803: Newport E360 Ventilator (2010), 1 descendant of its own
- K121891: Newport Aura Ventilator (2012), 0 descendants of its own

## Indications for use
The e500 Ventilator is intended to provide continuous (ET tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients with a tidal volume of > 20 mL. The device is prescription use only. The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility.

Source page: https://510kreport.com/device/K061094
Methodology: https://510kreport.com/methodology