# K030780: Newport E500 Wave Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Newport Medical Instruments, Inc.
- Decided: Jan 23, 2004 after 318 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) E200 Ventilator: named in the summary without a submission number
- (no number) Siemens Servo Ventilators: named in the summary without a submission number

## Most influential descendants
- K061094: Newport E500 Wave Ventilator (2006), 2 descendants of its own
- K053502: Newport E360 Ventilator (2006), 2 descendants of its own
- 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 noncontinuous (mask) ventilatory support and monitoring for infant, pedatric and adult patients with a tidal volume of > 20 mL. The device is prescription use only. The intended environments include hospital, hospitaltype 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/K030780
Methodology: https://510kreport.com/methodology