# K093126: Anapnoguard Endotracheal Tube

- Pathway: 510(k) (Traditional)
- Applicant: Hospitech Respiration, Ltd.
- Decided: Mar 2, 2010 after 151 days
- Product code: BTP (Dropper, Ether)
- Device class: 1
- Regulation: 21 CFR 868.5420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K961837 (1996). 8 ancestors in all.
3 later devices descend from it; 1 cites it directly.
4 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082520: Sealguard Evac Endotracheal and Endotracheal Tubes, Mallinckrodt Medical (2008) Summary page 2.
- K042683: Well Lead Endotracheal Tube, Well Lead Medical Instruments (2005) Summary page 2.

## Most influential descendants
- K150157: AnapnoGuard 100 Respiratory Guard System (2016), 2 descendants of its own
- K180991: AG 100s (2018), 1 descendant of its own
- K221477: AG100s (2022), 0 descendants of its own

## Indications for use
The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.

Source page: https://510kreport.com/device/K093126
Methodology: https://510kreport.com/methodology
