510(k) · Cleared
ClearedVirtuoso LX Smart 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 Oct 27, 1999 as substantially equivalent to K953930 (Respironics, Inc., 1996) after a 15-day review. Its family tree reaches back 1 generation to 1996. 12 of the 96 devices in its family, counting itself, have a Class I recall. 94 later devices descend from it.
- Decided
- Oct 27, 1999
- Review
- 15 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953930 (1996). 94 later devices descend from it, 3 citing it directly. 12 of the 96 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- This deviceK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- Descendant · cites it directly · 92 of its ownK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- Descendant · cites it directly · 74 of its ownK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- Descendant · 2 generations on · 47 of its ownK021861 Remstar Pro with C-Flex Cpap SystemRespironics, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 42 of its ownK052110 M-Series Pro Cpap SytemRespironics, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 40 of its ownK041010 Remstar Auto with C-Flex Cpap SystemRespironics, Inc. · 2004 · Recalled
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 94 · See all- K012554Remstar Auto Cpap SystemRespironics, Inc. · 2002 · cites it directly92descendants
- K031460Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003 · cites it directly74descendants
- K021861Remstar Pro with C-Flex Cpap SystemRespironics, Inc. · 2002 · 2 generations on47descendants
- K052110M-Series Pro Cpap SytemRespironics, Inc. · 2005 · 3 generations on42descendants
- K041010Remstar Auto with C-Flex Cpap SystemRespironics, Inc. · 2004 · 2 generations on40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| 0 (this device) | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| +1 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| +1 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| +2 | K021861 | Remstar Pro with C-Flex Cpap System | Respironics, Inc. | 2002 | 1 |
| +3 | K052110 | M-Series Pro Cpap Sytem | Respironics, Inc. | 2005 | 15 |
| +2 | K041010 | Remstar Auto with C-Flex Cpap System | Respironics, Inc. | 2004 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 1 |
| 2010 | 3 | 1 |
| 2011 | 3 | 3 |
| 2012 | 7 | 3 |
| 2013 | 10 | 2 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 1 |
| 2020 | 7 | 0 |
| 2021 | 3 | 1 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 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.
12 devices in this family have a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | K953930 | Virtuoso Smart Cpap SystemSummary page 1…de BZD - noncontinuous ventilator Common/Usual Name CPAP System Proprietary Name Respironics® Virtuoso LX Smart CPAP System Predicate Device Virtuoso Smart CPAP System (K953930) Keason for submission Modified design; additional accessories. Substantial Equivalence The modified device has the following s… | 1996 |
| † | K970173 | Model 1700 Tranquility Bilevel System | 1997 |
What descends from it? (94)
See all 943 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (12 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K122769Remstar SERespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 5 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K130077Remstar SERespironics, Inc. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 6 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K113068Remstar Auto a-Flex HTRespironics, Inc. · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 7 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · 7 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 7 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K131982Remstar Auto a-Flex HTRespironics, Inc. · 2013 · 7 generations on · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 8 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 9 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 10 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 12; all are on the web page.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K012554 (Respironics, Inc., 2002) has gone furthest, with 92 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 Virtuoso Smart LX CPAP System delivers continuous positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.
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/K993433 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993433: Virtuoso LX Smart 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/K993433
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