# K113714: Vpap TX

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: May 25, 2012 after 158 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- 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 K971260 (1997). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092186: Vpap TX, Resmed, Ltd. (2009) Summary page 1.

## Indications for use
The VPAP TX is indicated for the treatment and titration of patients weighing more than 66 lb (>30 kg) with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. The VPAP Tx is intended to be used in a clinical environment.

Source page: https://510kreport.com/device/K113714
Methodology: https://510kreport.com/methodology