# K180991: AG 100s

- Pathway: 510(k) (Traditional)
- Applicant: Hospitech Respiration, Ltd.
- Decided: Oct 12, 2018 after 179 days
- Product code: BSK (Cuff, Tracheal Tube, Inflatable)
- Device class: 2
- Regulation: 21 CFR 868.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K945062 (1995). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150157: AnapnoGuard 100 Respiratory Guard System, Hospitech Respiration, Ltd. (2016) Summary page 5.

## Most influential descendants
- K221477: AG100s (2022), 0 descendants of its own

## Indications for use
AG 100s is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube’s cuff.

Source page: https://510kreport.com/device/K180991
Methodology: https://510kreport.com/methodology