# K022642: Twlight, Model Isp 9600

- Pathway: 510(k) (Traditional)
- Applicant: Invacare Corp.
- Decided: Feb 11, 2003 after 187 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: 1 generation back to K982530 (1998). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982530: Sullivan Mirage Full Face Mask, Resmed, Ltd. (1998) Summary page 1.
- K993269: IQ Nasal Mask, Model P/N 50160, Sleepnet Corporation (1999) Summary page 1.

## Most influential descendants
- K061874: Invacare's Twilight II Nasal Masks (2006), 0 descendants of its own
- K042455: Devilbiss Nasal Cpap Mask, 9354 Series (2005), 0 descendants of its own

## Indications for use
The Invacare Model Twilight Nasal CPAP Mask is intended to be used with positive airway pressure devices such as CPAP, to provide 3-20 cmHz0 for the treatment of adult obstructive sleep apnea. 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 patient use.

Source page: https://510kreport.com/device/K022642
Methodology: https://510kreport.com/methodology