# K121705: GEO

- Pathway: 510(k) (Special)
- Applicant: Resmed, Ltd.
- Decided: Oct 23, 2012 after 137 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K971260 (1997). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112393: Tasman, Resmed, Ltd. (2011)

## Indications for use
The Geo is indicated for the treatment of obstructive sleep apnea (OSA) in adult patients weighing more than 66 lbs (30 kg). The Geo mask system delivers airflow noninvasively to a user from the integrated CPAP device. The Geo system is intended for single-patient re-use in the home environment and while traveling.

Source page: https://510kreport.com/device/K121705
Methodology: https://510kreport.com/methodology