# K121891: Newport Aura Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Newport Medical Instruments, Inc.
- Decided: Nov 9, 2012 after 133 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: 13 generations back to K902859 (1991). 94 ancestors in all.
No later device cites it as a predicate yet.
10 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090888: Newport HT70 Family of Ventilators, Newport Medical Instruments, Inc. (2009) Summary page 1.
- K111146: Newport HT70 Ventilator, Newport Medical Instruments, Inc. (2011)
- K053502: Newport E360 Ventilator, Newport Medical Instruments, Inc. (2006) Summary page 1.
- K101803: Newport E360 Ventilator, Newport Medical Instruments, Inc. (2010) Summary page 1.

## Indications for use
The AURA Family of Ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support through invasive or non-invasive interfaces to individuals that require such medical care. Specifically, the AURA Family of Ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.). The AURA ventilator is a restricted medical device intended for use by qualified, trained, personnel under the direction of a physician. The AURA ventilator is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

Source page: https://510kreport.com/device/K121891
Methodology: https://510kreport.com/methodology