510(k) · Cleared
ClearedTwlight, Model Isp 9600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corp. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Feb 11, 2003 as substantially equivalent to K982530 (Resmed, Ltd., 1998) and 1 other predicate after a 187-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Feb 11, 2003
- Review
- 187 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K982530 (1998). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK982530 Sullivan Mirage Full Face MaskResmed, Ltd. · 1998
- This deviceK022642 Twlight, Model Isp 9600Invacare Corp. · 2003
- Descendant · cites it directly · 0 of its ownK061874 Invacare's Twilight II Nasal MasksInvacare Corp. · 2006
- Descendant · cites it directly · 0 of its ownK042455 Devilbiss Nasal Cpap Mask, 9354 SeriesSunrise Medical · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982530 | Sullivan Mirage Full Face Mask | Resmed, Ltd. | 1998 | — |
| 0 (this device) | K022642 | Twlight, Model Isp 9600 | Invacare Corp. | 2003 | — |
| +1 | K061874 | Invacare's Twilight II Nasal Masks | Invacare Corp. | 2006 | — |
| +1 | K042455 | Devilbiss Nasal Cpap Mask, 9354 Series | Sunrise Medical | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZD device
- #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982530 | Sullivan Mirage Full Face MaskSummary page 1…9-6000 Facsimile: (440) 365-4558 Common or Usual Name CPAP Mask Classification Name Ventilator, Non-continuous Predicate Devices Resmed Corporation Mirage Nasal Mask (K982530), and the Sleepnet Corporation Model IQTM Nasal Mask (K993269). Intended Use The Invacare Model Twilight Nasal CPAP Mask is i… | 1998 |
| * | K993269 | IQ Nasal Mask, Model P/N 50160Summary page 1…sk Classification Name Ventilator, Non-continuous Predicate Devices Resmed Corporation Mirage Nasal Mask (K982530), and the Sleepnet Corporation Model IQTM Nasal Mask (K993269). Intended Use The Invacare Model Twilight Nasal CPAP Mask is intended to be used with positive airway pressure devices.su… | 1999 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022642 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022642: Twlight, Model Isp 9600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022642
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026