510(k) · Cleared
ClearedDevilbiss DV5M Smartlink System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Oct 28, 2008 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 5 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Oct 28, 2008
- Review
- 84 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- This deviceK082209 Devilbiss DV5M Smartlink SystemSunrise Medical · 2008
- Descendant · cites it directly · 1 of its ownK102465 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK152810 DeVilbiss DV6WM Wireless ModemDevilbiss Healthcare, LLC · 2016
- Descendant · cites it directly · 0 of its ownK140880 Devilbiss Smartlink II SystemDevilbiss Healthcare, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK111378 Oximetry Interface KitPhilips Respironics, Inc. · 2011 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · cites it directly1descendant
- K152810DeVilbiss DV6WM Wireless ModemDevilbiss Healthcare, LLC · 2016 · cites it directly0descendants
- K140880Devilbiss Smartlink II SystemDevilbiss Healthcare, LLC · 2014 · cites it directly0descendants
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082209 | Devilbiss DV5M Smartlink System | Sunrise Medical | 2008 | — |
| +1 | K102465 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2011 | Class I |
| +1 | K152810 | DeVilbiss DV6WM Wireless Modem | Devilbiss Healthcare, LLC | 2016 | — |
| +1 | K140880 | Devilbiss Smartlink II System | Devilbiss Healthcare, LLC | 2014 | — |
| +2 | K111378 | Oximetry Interface Kit | Philips Respironics, Inc. | 2011 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 2 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K102465 (Respironics, Inc., 2011) has gone furthest, with 1 descendant 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. 2008, 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 SmartLink System can only be used in conjunction with the DV51 and DV54 Series CPAP Systems for follow up of obstructive sleep apnea patients weighing above 30 kg on nasal CPAP therapy.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K082209 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082209: Devilbiss DV5M Smartlink System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082209
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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