# K082520: Sealguard Evac Endotracheal and Endotracheal Tubes

- Pathway: 510(k) (Special)
- Applicant: Mallinckrodt Medical
- Decided: Oct 2, 2008 after 30 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871204 (1987). 2 ancestors in all.
11 later devices descend from it; 2 cite it directly.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871204: Cuffed Tracheal Tube (Multiple), Mallinckrodt Critical Care (1987) Summary page 2.
- K965132: HI-LO Evac and Evac II Endotracheal Tubes, Mallinckrodt Medical (1997) Summary page 2.

## Most influential descendants
- K090352: Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal Tubes (2009), 6 descendants of its own
- K093126: Anapnoguard Endotracheal Tube (2010), 3 descendants of its own
- K150157: AnapnoGuard 100 Respiratory Guard System (2016), 2 descendants of its own
- K110269: Well Lead Endotracheal Tube with Evacuation Lumen-Oral (2011), 2 descendants of its own
- K180991: AG 100s (2018), 1 descendant of its own

## Recalls of this device
- Apr 4, 2016 · Class II · Z-1626-2016: Device packaging may not be sealed.
- Apr 4, 2016 · Class II · Z-1625-2016: Device packaging may not be sealed.

## Indications for use
The SealGuard Evac Endotracheal tube is indicated for airway management by oral/nasal intubation of the trachea, and for evacuation or drainage of the subglottic space. The SealGuard Endotracheal tube is a device inserted into a patient's trachea via the nose or mouth to maintain an open airway.

Source page: https://510kreport.com/device/K082520
Methodology: https://510kreport.com/methodology