# K051993: Lma Fastrach Ett Single Use

- Pathway: 510(k) (Traditional)
- Applicant: The Laryngeal Mask Co., Ltd.
- Decided: Dec 13, 2005 after 141 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: 5 generations back to K903730 (1990). 16 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991580: Ilm Endotracheal Tube, The Laryngeal Mask Co., Ltd. (2000) Summary page 1.
- K860105: Spiral-Flex, Sheridan Catheter Corp. (1986) Summary page 1.
- K990619: Rusch Reinforced Endotracheal (or Tracheal) Tube- Cuffed and Uncuffed Murphy/Magill, Sterile, Rusch Intl. (1999) Summary page 1.
- K032112: P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed), Portex, Ltd. (2004) Summary page 1.

## Most influential descendants
- K130304: Lma Family of Airways (2014), 4 descendants of its own
- K142103: Cuff Pilot, Sure Seal (2015), 3 descendants of its own
- K160694: Disposable Endotracheal tube, sterile, AccuCuff (2017), 1 descendant of its own
- K242495: LMA Fastrach ETT SU (2025), 0 descendants of its own
- K190274: Endotracheal Tube (2019), 0 descendants of its own

## Indications for use
The LMA Fastrach'TM ETT SU is indicated for airway management by oral intubation of the trachea. Reinforced ETT may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation.

Source page: https://510kreport.com/device/K051993
Methodology: https://510kreport.com/methodology