# K073702: Phoneris Inner Cannulae with Phoneris Aero-Flex Ventilator Circuit Connector

- Pathway: 510(k) (Traditional)
- Applicant: Lazarus Medical, LLC
- Decided: Jun 26, 2008 after 178 days
- Product code: BTO (Tube, Tracheostomy (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K811447 (1981). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811447: Shiley Disposable Cannula Trach. Tube, Shiley, Inc. (1981) Summary page 1.

## Indications for use
The Phoneris TM Inner Cannulae with Phoneris M T Aero-FlexTM Ventilator Circuit Connector is indicated for airway maintenance of tracheostomised patients. The single use, disposable device is an accessory to a tracheostomy tube, serving as an interlocking, detachable, coupling between the ventilator circuit and tracheostomy tube. The PhonerisTM Inner Cannulae component is designed to replace the disposable inner cannulae component of the Shiley Disposable Cannula Tracheostomy Tube.

Source page: https://510kreport.com/device/K073702
Methodology: https://510kreport.com/methodology