# K242495: LMA Fastrach ETT SU

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical
- Decided: Apr 29, 2025 after 250 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: 6 generations back to K903730 (1990). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051993: Lma Fastrach Ett Single Use, The Laryngeal Mask Co., Ltd. (2005) Summary page 5.

## Indications for use
The LMA® Fastrach™ ETT Single Use is indicated for tracheal intubation through the LMA® Fastrach™. The Stabiliser Rod is indicated for use during removal of the LMA® Fastrach™ and LMA® Fastrach™ Single Use after intubation to keep the LMA® Fastrach ™ ETT Single Use in place.

Source page: https://510kreport.com/device/K242495
Methodology: https://510kreport.com/methodology