510(k) · Cleared
ClearedDeVilbiss Intellipap2/DeVilbiss BLUE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devilbiss Healthcare, LLC · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Sep 18, 2015 as substantially equivalent to K071689 (Sunrise Medical, 2007) and 1 other predicate after a 268-day review. Its family tree reaches back 10 generations to 1996. 2 of the 33 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 18, 2015
- Review
- 268 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K953930 (1996). 32 ancestors in all, the oldest K930656 (1994). No later device cites it as a predicate yet. 2 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 6 generations between
- 3 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 2 generations backK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- 1 generation backK113068 Remstar Auto a-Flex HTRespironics, Inc. · 2011 · Recalled (Class I)
- This deviceK143677 DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC · 2015
Show all 10 generations
- Root · 10 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 9 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 8 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 7 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 6 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 5 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 4 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 3 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 2 generations backK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- 1 generation backK113068 Remstar Auto a-Flex HTRespironics, Inc. · 2011 · Recalled (Class I)
- This deviceK143677 DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC · 2015
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −9 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −8 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −7 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −6 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −5 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −4 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| −3 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| −2 | K091319 | Remstar Auto a-Flex | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| −1 | K113068 | Remstar Auto a-Flex HT | Respironics, Inc. | 2011 | Class I |
| 0 (this device) | K143677 | DeVilbiss Intellipap2/DeVilbiss BLUE | Devilbiss Healthcare, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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.
2 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071689 | Devilbiss Intellipap Model DV 5 SeriesSummary page 4…continuos respirator Predicate Device Name(s) and 510(k) DeVilbiss Intellipap DV5 Series cleared number(s): under K071689 and Respironics, Inc, Remstar Auto A-Flex HT cleared under… | 2007 |
| * | K113068 | Remstar Auto a-Flex HTSummary page 4…er K071689 and Respironics, Inc, Remstar Auto A-Flex HT cleared under K113068 Section 5.0 Page 1 of 11 Description of Device: The proposed DeVilbiss Intel… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 12 of the 32 ancestors have a recall of any class; 2 have a Class I recall.
- 3 other devices also cite its predicate K071689.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 DeVilbiss Intellipap2/DeVilbiss BLUE Series is intended for use in treating OSA in spontaneously breathing patients 30 Kg (66 lbs) and above by means of application of positive air pressure. The Device is to be used in Home and Healthcare Environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143677: DeVilbiss Intellipap2/DeVilbiss BLUE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143677
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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