# K221477: AG100s

- Pathway: 510(k) (Traditional)
- Applicant: Hospitech Respiration, Ltd.
- Decided: Dec 29, 2022 after 220 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: 8 generations back to K945062 (1995). 35 ancestors in all.
No later device cites it as a predicate yet.
4 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180991: AG 100s, Hospitech Respiration, Ltd. (2018) Summary page 4.
- K150893: IntelliCuff, Hamilton Medical AG (2016) Summary page 4.

## Indications for use
The AG100s is intended to monitor and control the cuff pressures of endotracheal tube (ETT) or tracheostomy tube (TT) and to evacuate secretions from the subglottic space above the cuff during mechanical ventilation. 1. When used with a standard ETT or TT, the device automatically maintains the cuff pressure as pre-set by the user. 2. When used with ETT or TT with suction line, the device automatically maintains the cuff pressure as pre-set by the user and performs intermittent evacuation of subglottic secretions from above the tube's cuff. 3. When used with ETT with suction and venting lines (e.g., AG ETT), the device automatically maintains the cuff pressure as pre-set by the user, or automatically adjusts the cuff pressure based on monitoring of the Carbon Dioxide (CO2) concentration above the cuff. In addition, it performs evacuation, or rinsing and evacuation of subglottic secretions from above the tube's cuff.

Source page: https://510kreport.com/device/K221477
Methodology: https://510kreport.com/methodology