# K991580: Ilm Endotracheal Tube

- Pathway: 510(k) (Traditional)
- Applicant: The Laryngeal Mask Co., Ltd.
- Decided: Feb 4, 2000 after 273 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
No predicates in its family tree.
8 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Euromedical™ ILM (Intubating Laryngeal mask) 100% Silicone Wire-Reinforced Endotracheal Tube: named in the summary without a submission number

## Most influential descendants
- K051993: Lma Fastrach Ett Single Use (2005), 6 descendants of its own
- 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

## Indications for use
The ILM Endotracheal Tube is indicated for airway management by oral intubation of the trachea.

Source page: https://510kreport.com/device/K991580
Methodology: https://510kreport.com/methodology