# K961449: Tracheostomy Tubes Tracoe-Flex

- Pathway: 510(k) (Traditional)
- Applicant: Tracoe Medical GmbH
- Decided: Sep 13, 1996 after 150 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 K781729 (1978). 14 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811033: Shiley Low Pressure Thin-Cuffed Trach, Shiley, Inc. (1981) Summary page 3.
- K880614: Shiley Disp. Cannula Cuffless Traceostomy Tube, Shiley, Inc. (1988) Summary page 3.
- K885130: Modified Aire-Cuf Silicone Tracheostomy Tube, Bivona Medical Technologies (1989) Summary page 3.
- K862267: Fome-Cuf and Aire Cuf Tracheostomy Tubes, Bivona Medical Technologies (1986) Summary page 3.
- K903730: D.I.C. Tracheostomy Tubes & Laryngectomy Tubes, Concord/Portex (1990) Summary page 3.
- K812302: Shiley Fenestrated Low Press. Cuffed, Shiley, Inc. (1981) Summary page 4.
- K865061: Shiley Dispos Cannula Fenes LP Cuffed Trache Tube, Shiley, Inc. (1987) Summary page 4.
- K810106: Shiley Single Cannula Tracheostomy Tube, Shiley, Inc. (1981) Summary page 4.
- K811447: Shiley Disposable Cannula Trach. Tube, Shiley, Inc. (1981) Summary page 4.
- K912124: Tracheostomy Tube and Cuff, Concord/Portex (1991) Summary page 4.
- K781729: Tracheotomy Tubes, Tracoe Medical GmbH (1978) Summary page 4.
- K821993: Shiley Laryngectomy Tube, Shiley, Inc. (1982) Summary page 4.
- K945406: SSV Phonate (TM) Shiley Speaking Valve, Mallinckrodt Medical Tpi, Inc. (1995) Summary page 4.
- K852272: Bivona Tracheostoma Valve II, Bivona Medical Technologies (1985) Summary page 4.

## Most influential descendants
- K120079: Primed Tracheostomy Tubes (Multiple) (2012), 2 descendants of its own
- K123699: Fahl Tracheostomy Tubes (Multiple) (2013), 1 descendant of its own
- K233713: Pilling Tracheostomy Tubes (2024), 0 descendants of its own

## Indications for use
Model 301: device is intended for providing tracheal access for airway management including artificial ventilation. Model 302: device is intended for providing tracheal access for airway management, in which a fenestration is needed in order to safely wean a patient from mechanical ventilation. It can also be used for phonation, if a patient with the larynx intact uses a fenestrated inner cannula with "speaking valve". Model 303: device is intended for providing tracheal access for airway management. Model 304: device is intended for providing tracheal access for airway management where a fenestration is needed in order to safely wean a patient from mechanical ventilation. It can also be used for phonation, if a patient with the larynx intact uses a fenestrated inner cannula with a "speaking valve". Model 305: device is intended for providing tracheal access for airway management in patients after laryngectomy Model 401: device is intended for use in patients with the larynx intact in combination with TRACOE®-FLEX model 302 and 304.

Source page: https://510kreport.com/device/K961449
Methodology: https://510kreport.com/methodology