510(k) · Cleared
ClearedNebulizer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthdyne, Inc. · BTI Compressor, Air, Portable
Cleared on Dec 1, 1992 after a 182-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Dec 1, 1992
- Review
- 182 days
- Class
- Class II
- Product code
- BTI
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK922623 Nebulizer SystemHealthdyne, Inc. · 1992
- Descendant · cites it directly · 4 of its ownK970289 Compressor/Nebulizer #3650Devilbiss Health Care, Inc. · 1997
- Descendant · 2 generations on · 3 of its ownK020932 Devilbiss Pulmo-Aide Compact CompressorSunrise Medical · 2002
- Descendant · 3 generations on · 0 of its ownK161586 The JLN-23XX Series Piston Compress Nebulizer (with models…Shenzhen Homed Medical Device Co., Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK082878 Nevoni Classic, Model 6600-PONsr Comercio E Representacoes Ltda · 2008
- Descendant · cites it directly · 0 of its ownK072163 Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 53A Health Care S.R.L. · 2008
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K970289Compressor/Nebulizer #3650Devilbiss Health Care, Inc. · 1997 · cites it directly4descendants
- K020932Devilbiss Pulmo-Aide Compact CompressorSunrise Medical · 2002 · 2 generations on3descendants
- K161586The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS…Shenzhen Homed Medical Device Co., Ltd. · 2017 · 3 generations on0descendants
- K082878Nevoni Classic, Model 6600-PONsr Comercio E Representacoes Ltda · 2008 · 3 generations on0descendants
- K072163Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 53A Health Care S.R.L. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922623 | Nebulizer System | Healthdyne, Inc. | 1992 | — |
| +1 | K970289 | Compressor/Nebulizer #3650 | Devilbiss Health Care, Inc. | 1997 | — |
| +2 | K020932 | Devilbiss Pulmo-Aide Compact Compressor | Sunrise Medical | 2002 | — |
| +3 | K161586 | The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS… | Shenzhen Homed Medical Device Co., Ltd. | 2017 | — |
| +3 | K082878 | Nevoni Classic, Model 6600-PO | Nsr Comercio E Representacoes Ltda | 2008 | — |
| +1 | K072163 | Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 5 | 3A Health Care S.R.L. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2017 | 1 | 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.
Planning a device in BTI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
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?
- Of its descendants, K970289 (Devilbiss Health Care, Inc., 1997) has gone furthest, with 4 descendants of its own.
How does its category compare?
All BTI devicesBTI Compressor, Air, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTI
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · BTI
Too few BTI 510(k)s in any year since 2007 to give a median.
Recalls per year · BTI
3in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · BTI
120in 2025
MAUDE reports naming product code BTI, 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 | 0 | — | 1 | 18 |
| 2008 | 1 | — | 0 | 9 |
| 2009 | 1 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 217 |
| 2013 | 1 | — | 1 | 1,710 |
| 2014 | 0 | — | 0 | 982 |
| 2015 | 0 | — | 0 | 294 |
| 2016 | 0 | — | 0 | 139 |
| 2017 | 0 | — | 0 | 103 |
| 2018 | 0 | — | 0 | 71 |
| 2019 | 0 | — | 0 | 114 |
| 2020 | 0 | — | 0 | 111 |
| 2021 | 0 | — | 0 | 278 |
| 2022 | 0 | — | 0 | 248 |
| 2023 | 0 | — | 3 (3) | 325 |
| 2024 | 0 | — | 0 | 166 |
| 2025 | 0 | — | 0 | 120 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K922623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922623: Nebulizer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922623
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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