# K962389: Euromedical Reinforced Endotracheal Tube

- Pathway: 510(k) (Traditional)
- Applicant: Unomedical Sdn Bhd
- Decided: Nov 21, 1996 after 154 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.
13 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K032112: P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) (2004), 12 descendants of its own
- K051993: Lma Fastrach Ett Single Use (2005), 6 descendants of its own
- K073383: Well Lead Reinforced Endotracheal Tube (2008), 5 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

Source page: https://510kreport.com/device/K962389
Methodology: https://510kreport.com/methodology