510(k) · Cleared
Recalled · 2007Bipap Duet LX 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 Jun 22, 2000 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 of the 105 devices in its family, counting itself, have a Class I recall. 104 later devices descend from it. It has been recalled once.
- Decided
- Jun 22, 2000
- Review
- 86 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 1
- Predicates
- 0
104 later devices descend from it, 1 citing it directly. 24 of the 105 devices in this family, counting this one, have a Class I recall.
- This deviceK000994 Bipap Duet LX BI-Level SystemRespironics, Inc. · 2000
- Descendant · cites it directly · 103 of its ownK011714 Bipap Pro BI-Level SystemRespironics, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 61 of its ownK020777 Bipap Synchrony Ventilatory Support System with BI-FlexRespironics, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 59 of its ownK070328 Bipap Synchrony with AvapsRespironics Inc., Sleep & Home Respiratory Group · 2007
- Descendant · 2 generations on · 52 of its ownK031656 Bipap Harmony Ventilatory Support SystemRespironics, Inc. · 2003
- Descendant · 2 generations on · 47 of its ownK021861 Remstar Pro with C-Flex Cpap SystemRespironics, Inc. · 2002 · Recalled
Showing 5 of 104 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 104 · See all- K011714Bipap Pro BI-Level SystemRespironics, Inc. · 2001 · cites it directly103descendants
- K020777Bipap Synchrony Ventilatory Support System with BI-FlexRespironics, Inc. · 2002 · 2 generations on61descendants
- K070328Bipap Synchrony with AvapsRespironics Inc., Sleep & Home Respiratory Group · 2007 · 3 generations on59descendants
- K031656Bipap Harmony Ventilatory Support SystemRespironics, Inc. · 2003 · 2 generations on52descendants
- K021861Remstar Pro with C-Flex Cpap SystemRespironics, Inc. · 2002 · 2 generations on47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000994 | Bipap Duet LX BI-Level System | Respironics, Inc. | 2000 | — |
| +1 | K011714 | Bipap Pro BI-Level System | Respironics, Inc. | 2001 | 1 |
| +2 | K020777 | Bipap Synchrony Ventilatory Support System with BI-Flex | Respironics, Inc. | 2002 | 2 |
| +3 | K070328 | Bipap Synchrony with Avaps | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| +2 | K031656 | Bipap Harmony Ventilatory Support System | Respironics, Inc. | 2003 | — |
| +2 | K021861 | Remstar Pro with C-Flex Cpap System | Respironics, Inc. | 2002 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 1 | 0 |
| 2009 | 10 | 5 |
| 2010 | 5 | 2 |
| 2011 | 8 | 5 |
| 2012 | 13 | 3 |
| 2013 | 8 | 3 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 6 | 1 |
| 2017 | 2 | 1 |
| 2018 | 2 | 1 |
| 2019 | 3 | 2 |
| 2020 | 3 | 0 |
| 2021 | 2 | 1 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
24 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (104)
See all 1041 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011714 | Bipap Pro BI-Level System | 2001 | 103 |
Has anything in its family been recalled? (24 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2007 | Not classified | Z-1081-2008 | 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.
- K090248Bipap AutosvRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 14 Class I recalls
- K090539Bipap Autosv AdvancedRespironics Inc., Sleep & Home Respiratory Group · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 15 Class I recalls
- 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
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 18 Class I recalls
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K130077Remstar SERespironics, Inc. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
Nearest 12 of 24 shown.
Nearest 5 of 24; all are on the web page.
What does this lineage say?
- Of its descendants, K011714 (Respironics, Inc., 2001) has gone furthest, with 103 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) | — |
https://510kreport.com/device/K000994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000994: Bipap Duet LX BI-Level System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000994
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026