510(k) · Cleared
ClearedInvacare Cpap
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 Jan 27, 1999 as substantially equivalent to K930656 (Rescare, Ltd., 1994) and 1 other predicate after a 216-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Jan 27, 1999
- Review
- 216 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K952292 (1995). 4 ancestors in all, the oldest K930656 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 1 generation backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- This deviceK982242 Invacare CpapInvacare Corp. · 1999
- Descendant · cites it directly · 0 of its ownK041823 Pioneer U121 Series CpapMerits Health Products Co., Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK031064 Invacare Polaris EX Cpap, Model ISP3000Invacare Corp. · 2004
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 |
|---|---|---|---|---|---|
| −2 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −1 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| 0 (this device) | K982242 | Invacare Cpap | Invacare Corp. | 1999 | — |
| +1 | K041823 | Pioneer U121 Series Cpap | Merits Health Products Co., Ltd. | 2005 | — |
| +1 | K031064 | Invacare Polaris EX Cpap, Model ISP3000 | Invacare Corp. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K930656 | Sullivan Iii Nasal Cpap SystemSummary page 1…Usual Name CPAP Classification Name Ventilator, Noncontinuous Predicate Devices The Invacare CPAP is substantially equivalent to the Resmed Sullivan V CPAP System (K930656, 3/15/94) and the Respironics Solo CPAP System (K961626, 7/18/96). Intended Use The intended function and use is of the Invacare… | 1994 |
| * | K961626 | Solo Cpap SystemSummary page 1…ontinuous Predicate Devices The Invacare CPAP is substantially equivalent to the Resmed Sullivan V CPAP System (K930656, 3/15/94) and the Respironics Solo CPAP System (K961626, 7/18/96). Intended Use The intended function and use is of the Invacare CPAP is to treat Obstructive Sleep Apnea (OSA) in the h… | 1996 |
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K041823 (Merits Health Products Co., Ltd., 2005) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K930656.
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?
To treat Obstructive Sleep Apnea (OSA) in adults by delivering continuous positive airway pressure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982242: Invacare Cpap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982242
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