# K965132: HI-LO Evac and Evac II Endotracheal Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Medical
- Decided: Mar 20, 1997 after 87 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.
40 later devices descend from it; 7 cite it directly.
4 of 41 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
- K030570: Blue Line Ultra Suctionaid Tracheostomy Tube (2003), 21 descendants of its own
- K032112: P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) (2004), 12 descendants of its own
- K082520: Sealguard Evac Endotracheal and Endotracheal Tubes (2008), 11 descendants of its own
- K090352: Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal Tubes (2009), 6 descendants of its own
- K051993: Lma Fastrach Ett Single Use (2005), 6 descendants of its own

Source page: https://510kreport.com/device/K965132
Methodology: https://510kreport.com/methodology