# K080339: Medsource Endotracheal Tube (with and Without Cuff)

- Pathway: 510(k) (Traditional)
- Applicant: Medsource International, LLC
- Decided: Oct 27, 2008 after 262 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: 3 generations back to K961837 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
4 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925505: Rusch Safety Clear Plus Cuffed W/Murphy Eye, Rusch, Inc. (1993) Summary page 3.
- K925506: Rusch Safety Clear Uncuffed with Murphy Eye, Rusch, Inc. (1993) Summary page 3.
- K952100: Rusch Endotracheal Tube Stylet, Rusch, Inc. (1995) Summary page 3.
- K031794: Endoflex Tracheal Tube, Merlyn Associates, Inc. (2004) Summary page 3.
- K042683: Well Lead Endotracheal Tube, Well Lead Medical Instruments (2005) Summary page 3.

## Indications for use
The device is intended for oral or nasal intubation and for airway management. The device is intended for oral or nasal intubation and for airway management.

Source page: https://510kreport.com/device/K080339
Methodology: https://510kreport.com/methodology