510(k) · Cleared
ClearedCompressor/Nebulizer #3650
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devilbiss Health Care, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Apr 15, 1997 as substantially equivalent to K923888 (Devilbiss Health Care, Inc., 1993) and 1 other predicate after an 81-day review. Its family tree reaches back 1 generation to 1992. 4 later devices descend from it.
- Decided
- Apr 15, 1997
- Review
- 81 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922623 (1992). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK922623 Nebulizer SystemHealthdyne, Inc. · 1992
- This deviceK970289 Compressor/Nebulizer #3650Devilbiss Health Care, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK020932 Devilbiss Pulmo-Aide Compact CompressorSunrise Medical · 2002
- Descendant · 2 generations on · 0 of its ownK161586 The JLN-23XX Series Piston Compress Nebulizer (with models…Shenzhen Homed Medical Device Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK082878 Nevoni Classic, Model 6600-PONsr Comercio E Representacoes Ltda · 2008
- Descendant · 2 generations on · 0 of its ownK062952 C300 Series Air Nebulizer CompressorChoice Smart Health Care Co., Ltd. · 2007
Most influential descendants
Showing 4 of 4 · See all- K020932Devilbiss Pulmo-Aide Compact CompressorSunrise Medical · 2002 · cites it directly3descendants
- K161586The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS…Shenzhen Homed Medical Device Co., Ltd. · 2017 · 2 generations on0descendants
- K082878Nevoni Classic, Model 6600-PONsr Comercio E Representacoes Ltda · 2008 · 2 generations on0descendants
- K062952C300 Series Air Nebulizer CompressorChoice Smart Health Care Co., Ltd. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922623 | Nebulizer System | Healthdyne, Inc. | 1992 | — |
| 0 (this device) | K970289 | Compressor/Nebulizer #3650 | Devilbiss Health Care, Inc. | 1997 | — |
| +1 | K020932 | Devilbiss Pulmo-Aide Compact Compressor | Sunrise Medical | 2002 | — |
| +2 | K161586 | The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS… | Shenzhen Homed Medical Device Co., Ltd. | 2017 | — |
| +2 | K082878 | Nevoni Classic, Model 6600-PO | Nsr Comercio E Representacoes Ltda | 2008 | — |
| +2 | 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 |
|---|---|---|
| 2002 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K923888 | Devilbiss Model 5650 Pulmo-AideSummary page 1…Compressor / Nebulizer is substantially equivalent to legally marketed predicate devices. Legally Marketed Predicate Devices 510(k) Registration # DeVilbiss Model 5650 K 923888 Healthdyne, Inc. 323 K 922623 3650pt3.doc 01/23/97 | 1993 |
| * | K922623 | Nebulizer SystemSummary page 1…stantially equivalent to legally marketed predicate devices. Legally Marketed Predicate Devices 510(k) Registration # DeVilbiss Model 5650 K 923888 Healthdyne, Inc. 323 K 922623 3650pt3.doc 01/23/97 | 1992 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020932 | Devilbiss Pulmo-Aide Compact Compressor | 2002 | 3 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K020932 (Sunrise Medical, 2002) has gone furthest, with 3 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 Model 3650 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970289 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970289: Compressor/Nebulizer #3650.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970289
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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