510(k) · Cleared
ClearedBipap Pro 2 BI-Level 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 Mar 4, 2004 as substantially equivalent to K011714 (Respironics, Inc., 2001) and 4 other predicates after a 175-day review. Its family tree reaches back 4 generations to 1996. 12 of the 54 devices in its family, counting itself, have a Class I recall. 40 later devices descend from it.
- Decided
- Mar 4, 2004
- Review
- 175 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K953930 (1996). 13 ancestors in all, the oldest K961783 (1996). 40 later devices descend from it, 1 citing it directly. 12 of the 54 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 3 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 2 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 1 generation backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- This deviceK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- Descendant · cites it directly · 39 of its ownK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- Descendant · 2 generations on · 37 of its ownK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 35 of its ownK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- Descendant · 4 generations on · 22 of its ownK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- Descendant · 5 generations on · 11 of its ownK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 40 · See all- K043607Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005 · cites it directly39descendants
- K050759Bipap AutoRespironics, Inc. · 2005 · 2 generations on37descendants
- K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · 3 generations on35descendants
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 4 generations on22descendants
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 5 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −3 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −2 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −1 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| 0 (this device) | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| +1 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| +2 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| +3 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| +4 | K091319 | Remstar Auto a-Flex | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| +5 | K092818 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2010 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 1 |
| 2010 | 2 | 1 |
| 2011 | 3 | 3 |
| 2012 | 5 | 3 |
| 2013 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K011714 | Bipap Pro BI-Level SystemSummary page 1…Proprietary Name Respironics BiPAP Pro 2 Bi-level System Predicate Device(s) Respironics BiPAP Pro Bi-level System (K01 1714) Respironics REMstar Auto CPAP System (K01 2554 & K031460)… | 2001 |
| * | K012554 | Remstar Auto Cpap SystemSummary page 1…edicate Device(s) Respironics BiPAP Pro Bi-level System (K01 1714) Respironics REMstar Auto CPAP System (K01 2554 & K031460) Respironics BiPAP Harmony Ventilatory Support System (K031656)… | 2002 |
| * | K031460 | Modification to Remstar Auto Cpap SystemSummary page 1…ice(s) Respironics BiPAP Pro Bi-level System (K01 1714) Respironics REMstar Auto CPAP System (K01 2554 & K031460) Respironics BiPAP Harmony Ventilatory Support System (K031656)… | 2003 |
| * | K031656 | Bipap Harmony Ventilatory Support SystemSummary page 1…Respironics REMstar Auto CPAP System (K01 2554 & K031460) Respironics BiPAP Harmony Ventilatory Support System (K031656) Resmed VPAP IIST Nasal VPAP System (K961783) Reason for submission… | 2003 |
| * | K961783 | Sullivan Vpap II ST Nasal Vpap SystemSummary page 1…Respironics BiPAP Harmony Ventilatory Support System (K031656) Resmed VPAP IIST Nasal VPAP System (K961783) Reason for submission Modified design. ©2003 Respironics Inc. 9… | 1996 |
What descends from it? (40)
See all 401 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043607 | Bipap Pro 2 BI-Level System with BI-Flex | 2005 | 39 |
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.
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K113068Remstar Auto a-Flex HTRespironics, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K131982Remstar Auto a-Flex HTRespironics, Inc. · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls
- K122769Remstar SERespironics, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 7 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K130077Remstar SERespironics, Inc. · 2013 · 7 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 8 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 9 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 8 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K043607 (Respironics, Inc., 2005) has gone furthest, with 39 descendants of its own.
- 3 other devices also cite its predicate K011714.
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 BiPAP Pro 2 Bi-level System delivers positive airway pressure therapy
for the treatment of Obstructive Sleep Apnea only.
For use in the home or hospital/institutional environment on adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032834 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032834: Bipap Pro 2 BI-Level System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032834
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