# K053502: Newport E360 Ventilator

- Pathway: 510(k) (Special)
- Applicant: Newport Medical Instruments, Inc.
- Decided: Jan 10, 2006 after 25 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K030780 (2004). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 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.

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

## Recalls of this device
- Apr 14, 2010 · Not classified · Z-1617-2010: The recall was initiated due to a recent increase in complaints related to the early failure of a low pressure transducer which is on Printed Circuit Board (PCB) 2104A in the Newport e360 ventilator. 
- Oct 27, 2009 · Not classified · Z-2468-2011: Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered.
- Dec 15, 2008 · Not classified · Z-2029-2009: In December 2008, Newport initiated a field correction to upgrade e360 ventilators with software versions 3.0 or higher to software version 3.3. As a result of this upgrade, some customers experienced

## Indications for use
The e360 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/K053502
Methodology: https://510kreport.com/methodology