# K031794: Endoflex Tracheal Tube

- Pathway: 510(k) (Traditional)
- Applicant: Merlyn Associates, Inc.
- Decided: Mar 12, 2004 after 276 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- 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 K871204 (1987). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871204: Cuffed Tracheal Tube (Multiple), Mallinckrodt Critical Care (1987) Summary page 1.

## Most influential descendants
- K080339: Medsource Endotracheal Tube (with and Without Cuff) (2008), 0 descendants of its own

## Indications for use
The EndoFlex Tracheal Tube is intended for airway management by oral/nasal intubation.

Source page: https://510kreport.com/device/K031794
Methodology: https://510kreport.com/methodology