# K061874: Invacare's Twilight II Nasal Masks

- Pathway: 510(k) (Traditional)
- Applicant: Invacare Corp.
- Decided: Sep 5, 2006 after 64 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: 2 generations back to K982530 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022642: Twlight, Model Isp 9600, Invacare Corp. (2003) Summary page 1.
- K030798: Mirage Activa Mask, Resmed, Ltd. (2003) Summary page 1.

## Indications for use
The Invacare Model Twilight II Nasal Mask is intended to be used with positive airway pressure devices such as CPAP, for the treatment of adult obstructive sleep apnea. There is a port on the mask swivel to allow for pressure measurement. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single or multiple patient re-use.

Source page: https://510kreport.com/device/K061874
Methodology: https://510kreport.com/methodology