# K970811: Disposable Cannula Tracheostomy Tube, with Inner Cannula;Disposable Cannula Fenestrated Tracheostomy Tube, with Inner CN

- Pathway: 510(k) (Traditional)
- Applicant: Pneumocare, Inc.
- Decided: Nov 13, 1998 after 618 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K903730: D.I.C. Tracheostomy Tubes & Laryngectomy Tubes, Concord/Portex (1990) Summary page 1.

## Indications for use
The Disposable Cannula Tracheostomy Tubes are designed to provide an adult tracheostomy patient with an effective airway for breathing and/or ventilation.

Source page: https://510kreport.com/device/K970811
Methodology: https://510kreport.com/methodology