510(k) · Cleared
ClearedSolo Cpap System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Jul 18, 1996 as substantially equivalent to K953341 (Respironics, Inc., 1996) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1995. 114 later devices descend from it.
- Decided
- Jul 18, 1996
- Review
- 83 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K952292 (1995). 2 ancestors in all. 114 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- This deviceK961626 Solo Cpap SystemRespironics, Inc. · 1996
- Descendant · cites it directly · 110 of its ownK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- Descendant · 2 generations on · 98 of its ownK040941 Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004
- Descendant · 3 generations on · 74 of its ownK041900 HC604 Cpap HumidifierFisher & Paykel Healthcare, Ltd. · 2004
- Descendant · 4 generations on · 33 of its ownK082605 Vpap Auto with Humidaire 3IResmed, Ltd. · 2009
- Descendant · 5 generations on · 31 of its ownK091947 S8 Aspen with H4I PlusResmed, Ltd. · 2009
Showing 5 of 114 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 114 · See all- K973161Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998 · cites it directly110descendants
- K040941Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004 · 2 generations on98descendants
- K041900HC604 Cpap HumidifierFisher & Paykel Healthcare, Ltd. · 2004 · 3 generations on74descendants
- K082605Vpap Auto with Humidaire 3IResmed, Ltd. · 2009 · 4 generations on33descendants
- K091947S8 Aspen with H4I PlusResmed, Ltd. · 2009 · 5 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| 0 (this device) | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| +1 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| +2 | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| +3 | K041900 | HC604 Cpap Humidifier | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| +4 | K082605 | Vpap Auto with Humidaire 3I | Resmed, Ltd. | 2009 | — |
| +5 | K091947 | S8 Aspen with H4I Plus | Resmed, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 8 | 0 |
| 2013 | 9 | 0 |
| 2014 | 8 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 12 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K953341 | Aria Cpap SystemSummary page 1…15668 Classification Name 21 CFR 868.5905, 73 BZD Common/Usual Name Ventilator, Noncontinuous Proprietary Name Solo CPAP System Predicate Devices Aria CPAP Systern - K953341 Respironics, Inc. 1001 Murry Ridge Drive Murrysville, PA 15668 Companion 314 Nasal CPAP System - K952292 Nellcor Puritan-Bennett… | 1996 |
| * | K952292 | Puritan-Bennett Companion Nasal Cpap SystemSummary page 1…ry Name Solo CPAP System Predicate Devices Aria CPAP Systern - K953341 Respironics, Inc. 1001 Murry Ridge Drive Murrysville, PA 15668 Companion 314 Nasal CPAP System - K952292 Nellcor Puritan-Bennett 10800 Pflumm Road Lenexa, KS 66215 © 1996 Respironics, Inc. April 23, 1596 Sectinn 12, Page 1 === Pag… | 1995 |
What descends from it? (114)
See all 1142 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K973161 (Fisher & Paykel Electronics, Ltd., 1998) has gone furthest, with 110 descendants of its own.
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 Respironics Solo CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA) only. The Solo CPAP System may be used in clinical settings (hospitals & sleep labs) and in home environments, and must be prescribed by a physician. It is not intended for life support or life sustaining applications. The device is used in conjunction with a mask (various styles and sizes available), headgear, and a combination of breathing circuit accessories.
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/K961626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961626: Solo Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961626
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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