# K112393: Tasman

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Nov 16, 2011 after 89 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: 4 generations back to K971260 (1997). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033841: Resmed S8 Prime Cpap System, Resmed, Ltd. (2004) Summary page 1.
- K050359: Ultra Mirage II Mask, Resmed, Ltd. (2005) Summary page 1.

## Most influential descendants
- K121705: GEO (2012), 0 descendants of its own

## Indications for use
The Tasman is indicated for the treatment of obstructive sleep apnea (OSA) in adult patients weighing more than 66 lb (>30 Kg). The Tasman mask system delivers airflow noninvasively to a user from the integrated Continuous Positive Airway (CPAP) device. The Tasman is intended for single-patient re-use in the home environment and while travelling.

Source page: https://510kreport.com/device/K112393
Methodology: https://510kreport.com/methodology