510(k) · Cleared
Recalled · 2007Remstar Pro with C-Flex 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 Jun 19, 2002 as substantially equivalent to K012554 (Respironics, Inc., 2002) and 1 other predicate after a 13-day review. Its family tree reaches back 3 generations to 1996. 12 of the 55 devices in its family, counting itself, have a Class I recall. 47 later devices descend from it. It has been recalled once.
- Decided
- Jun 19, 2002
- Review
- 13 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K953930 (1996). 7 ancestors in all. 47 later devices descend from it, 4 citing it directly. 12 of the 55 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 2 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 1 generation backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- This deviceK021861 Remstar Pro with C-Flex Cpap SystemRespironics, Inc. · 2002
- Descendant · cites it directly · 42 of its ownK052110 M-Series Pro Cpap SytemRespironics, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 35 of its ownK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- Descendant · 3 generations on · 22 of its ownK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- Descendant · 4 generations on · 11 of its ownK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
- Descendant · 3 generations on · 10 of its ownK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 47 · See all- K052110M-Series Pro Cpap SytemRespironics, Inc. · 2005 · cites it directly42descendants
- K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · 2 generations on35descendants
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations on22descendants
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 4 generations on11descendants
- K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −2 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −1 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| 0 (this device) | K021861 | Remstar Pro with C-Flex Cpap System | Respironics, Inc. | 2002 | — |
| +1 | K052110 | M-Series Pro Cpap Sytem | Respironics, Inc. | 2005 | 15 |
| +2 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| +3 | K091319 | Remstar Auto a-Flex | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| +4 | K092818 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2010 | Class I |
| +3 | K071560 | Provent Nasal Dilator, Model BR2 | Ventus Medical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 1 |
| 2010 | 3 | 1 |
| 2011 | 3 | 3 |
| 2012 | 6 | 3 |
| 2013 | 5 | 2 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 1 |
| 2020 | 3 | 0 |
| 2021 | 2 | 1 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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.
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? (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.
What descends from it? (47)
See all 474 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2007 | Not classified | Z-1069-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
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 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K130077Remstar SERespironics, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K113068Remstar Auto a-Flex HTRespironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K131982Remstar Auto a-Flex HTRespironics, Inc. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 7 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 8 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?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K052110 (Respironics, Inc., 2005) has gone furthest, with 42 descendants of its own.
- 6 other devices also cite its predicate K012554.
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 REMstar Pro with C-Flex CPAP System is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only.
For use in the home or hospitallinstitutional environment on adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021861 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021861: Remstar Pro with C-Flex Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021861
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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