510(k) · Cleared
ClearedSidestream Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inspired Medical Products, Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jul 30, 1999 as substantially equivalent to K924123 (Medic-Aid, Ltd., 1992) and 1 other predicate after a 71-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.
- Decided
- Jul 30, 1999
- Review
- 71 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K914152 (1992). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK914152 Sidestream Drug NebulizerMedic-Aid, Ltd. · 1992
- This deviceK991725 Sidestream NebulizerInspired Medical Products, Ltd. · 1999
- 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
- Descendant · cites it directly · 0 of its ownK062484 Flaem Nuova RF6 Basic and RF6 Plus NebulizersFlaem Nuova S.P.A. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914152 | Sidestream Drug Nebulizer | Medic-Aid, Ltd. | 1992 | — |
| 0 (this device) | K991725 | Sidestream Nebulizer | Inspired Medical Products, Ltd. | 1999 | — |
| +1 | K072163 | Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 5 | 3A Health Care S.R.L. | 2008 | — |
| +1 | K062484 | Flaem Nuova RF6 Basic and RF6 Plus Nebulizers | Flaem Nuova S.P.A. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K924123 | Sidestream DisposableSummary page 1…m Drug Nebulizer Common/Usual Name: Nebulizer Classification Name: Nebulizer, Medicinal, Non-ventilatory (atomizer) Predicate Devices: Medic-Aid - Sidestream Nebulizer - K924123 Medic-Aid - Sidestream Nebulizer - K914152B evice Description: The Inspired Medical Products Sidestream Nebulizer is identical… | 1992 |
| * | K914152 | Sidestream Drug NebulizerSummary page 1…r Classification Name: Nebulizer, Medicinal, Non-ventilatory (atomizer) Predicate Devices: Medic-Aid - Sidestream Nebulizer - K924123 Medic-Aid - Sidestream Nebulizer - K914152B evice Description: The Inspired Medical Products Sidestream Nebulizer is identical to the Medic-Aid Sidestream Nebulizer clear… | 1992 |
What descends from it? (2)
2 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K072163 (3A Health Care S.R.L., 2008) 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?
A hand-held nebulizer to aerosolize commonly prescribed liquid drugs (except pentamadine) for inhalation by patients in the Home, Hospital and Nursing Home settings - anywhere aerosolized drug delivery is utilized.
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/K991725 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991725: Sidestream Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991725
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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