510(k) · Cleared
ClearedDevilbiss Pulmo-Aide Compact Compressor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical · CAF Nebulizer (Direct Patient Interface)
Cleared on Jun 28, 2002 as substantially equivalent to K970289 (Devilbiss Health Care, Inc., 1997) after a 98-day review. Its family tree reaches back 2 generations to 1992. 3 later devices descend from it.
- Decided
- Jun 28, 2002
- Review
- 98 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922623 (1992). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK922623 Nebulizer SystemHealthdyne, Inc. · 1992
- 1 generation backK970289 Compressor/Nebulizer #3650Devilbiss Health Care, Inc. · 1997
- This deviceK020932 Devilbiss Pulmo-Aide Compact CompressorSunrise Medical · 2002
- Descendant · cites it directly · 0 of its ownK161586 The JLN-23XX Series Piston Compress Nebulizer (with models…Shenzhen Homed Medical Device Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK082878 Nevoni Classic, Model 6600-PONsr Comercio E Representacoes Ltda · 2008
- Descendant · cites it directly · 0 of its ownK062952 C300 Series Air Nebulizer CompressorChoice Smart Health Care Co., Ltd. · 2007
Most influential descendants
Showing 3 of 3 · See all- K161586The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS…Shenzhen Homed Medical Device Co., Ltd. · 2017 · cites it directly0descendants
- K082878Nevoni Classic, Model 6600-PONsr Comercio E Representacoes Ltda · 2008 · cites it directly0descendants
- K062952C300 Series Air Nebulizer CompressorChoice Smart Health Care Co., Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922623 | Nebulizer System | Healthdyne, Inc. | 1992 | — |
| −1 | K970289 | Compressor/Nebulizer #3650 | Devilbiss Health Care, Inc. | 1997 | — |
| 0 (this device) | K020932 | Devilbiss Pulmo-Aide Compact Compressor | Sunrise Medical | 2002 | — |
| +1 | K161586 | The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS… | Shenzhen Homed Medical Device Co., Ltd. | 2017 | — |
| +1 | K082878 | Nevoni Classic, Model 6600-PO | Nsr Comercio E Representacoes Ltda | 2008 | — |
| +1 | K062952 | C300 Series Air Nebulizer Compressor | Choice Smart Health Care Co., Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2017 | 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.
Planning a device in CAF? 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 CAF device
- #1 K260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)score 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K970289 | Compressor/Nebulizer #3650Summary page 1…Predicate Devices: Legally Marketed Predicate Devices 510(k) Registration # DeVilbiss Model 3650 K 970289 Description of Device: The DeVilbiss Model 3655 Compressor/Nebulizer is a small, piston-type air compressor, sized to provide… | 1997 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K161586 (Shenzhen Homed Medical Device Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAF
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAF
1in 2018
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · CAF
191in 2025
MAUDE reports naming product code CAF, 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 | 18 | 98 | 1 | 26 |
| 2008 | 12 | 123 | 0 | 11 |
| 2009 | 8 | 163 | 0 | 15 |
| 2010 | 10 | 114 | 0 | 37 |
| 2011 | 10 | 157 | 1 | 237 |
| 2012 | 9 | 126 | 0 | 138 |
| 2013 | 9 | 238 | 0 | 217 |
| 2014 | 9 | 151 | 5 | 123 |
| 2015 | 8 | 186 | 3 | 166 |
| 2016 | 5 | 186 | 1 | 201 |
| 2017 | 8 | 253 | 14 (13) | 256 |
| 2018 | 9 | 161 | 1 | 162 |
| 2019 | 3 | 266 | 0 | 185 |
| 2020 | 6 | 219 | 0 | 117 |
| 2021 | 8 | 324 | 0 | 161 |
| 2022 | 4 | 176 | 0 | 55 |
| 2023 | 8 | 279 | 0 | 107 |
| 2024 | 4 | 251 | 0 | 102 |
| 2025 | 7 | 211 | 0 | 191 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The DeVilbiss compressor / nebulizer Model 3655 includes an AC powered air compressor that provides a source of compressed air for home health care use. The compressor is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020932 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020932: Devilbiss Pulmo-Aide Compact Compressor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020932
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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