# K152664: TAV System

- Pathway: 510(k) (Traditional)
- Applicant: New Aera, Inc.
- Decided: Dec 2, 2016 after 442 days
- Product code: ONZ (Mechanical Ventilator)
- 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: 11 generations back to K902859 (1991). 23 ancestors in all.
No later device cites it as a predicate yet.
2 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131562: Breathe Niov Ventilation System, Breathe Technologies (2014) Summary page 4.

## Indications for use
The New Aera Tidal Assist™ Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregivers under the direction of a physician.

Source page: https://510kreport.com/device/K152664
Methodology: https://510kreport.com/methodology