510(k) · Cleared
ClearedMicro Mist (TM) Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hudson Respiratory Care, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Sep 29, 1993 after a 239-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Sep 29, 1993
- Review
- 239 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 6 citing it directly.
- This deviceK930525 Micro Mist (TM) NebulizerHudson Respiratory Care, Inc. · 1993
- Descendant · cites it directly · 4 of its ownK052811 Hsiner Jet Nebulizer, Model HS-31100Hsiner Co., Ltd. · 2005
- Descendant · cites it directly · 3 of its ownK112859 Erapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK223840 eRapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK091272 Besmed Jet Nebulizer Bottle SetBesmed Health Business Corp · 2009 · Recalled
- Descendant · cites it directly · 1 of its ownK080230 Neb-U-Mask System, Models 1895, 1896Teleflexmedical, Inc. · 2008
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K052811Hsiner Jet Nebulizer, Model HS-31100Hsiner Co., Ltd. · 2005 · cites it directly4descendants
- K112859Erapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2012 · cites it directly3descendants
- K223840eRapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2023 · 2 generations on1descendant
- K091272Besmed Jet Nebulizer Bottle SetBesmed Health Business Corp · 2009 · 2 generations on1descendant
- K080230Neb-U-Mask System, Models 1895, 1896Teleflexmedical, Inc. · 2008 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930525 | Micro Mist (TM) Nebulizer | Hudson Respiratory Care, Inc. | 1993 | — |
| +1 | K052811 | Hsiner Jet Nebulizer, Model HS-31100 | Hsiner Co., Ltd. | 2005 | — |
| +1 | K112859 | Erapid Nebulizer System | Pari Respiratory Equipment, Inc. | 2012 | — |
| +2 | K223840 | eRapid Nebulizer System | Pari Respiratory Equipment, Inc. | 2023 | — |
| +2 | K091272 | Besmed Jet Nebulizer Bottle Set | Besmed Health Business Corp | 2009 | 1 |
| +1 | K080230 | Neb-U-Mask System, Models 1895, 1896 | Teleflexmedical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 146 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, K052811 (Hsiner Co., Ltd., 2005) has gone furthest, with 4 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 | — |
https://510kreport.com/device/K930525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K930525: Micro Mist (TM) Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930525
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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