510(k) · Cleared
ClearedFoshan Care Medical Nebulizer Model KYWH2001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foshan Care Medical Technology Co., Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on Mar 14, 2011 after a 283-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 14, 2011
- Review
- 283 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
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What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 Foshan Care Medical Nebulizer Compressor, Model KYWH2001, includes an AC powered air compressor that provides a source of compressed air. The compressor is used in conjunction with the Hsiner Disposable Nebulizer, Model Number HS-3 1100, to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The Foshan Care Medical Nebulizer Compressor, Model KYWH2001 is intended to aerosolize physician-prescribed solutions for…
Read the full statement (116 words)
The Foshan Care Medical Nebulizer Compressor, Model KYWH2001, includes an AC powered air compressor that provides a source of compressed air. The compressor is used in conjunction with the Hsiner Disposable Nebulizer, Model Number HS-3 1100, to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The Foshan Care Medical Nebulizer Compressor, Model KYWH2001 is intended to aerosolize physician-prescribed solutions for inhalation that are approved for nebulization. The Foshan Care Medical Nebulizer Compressor, Model KYWH2001 is intended for adult and pediatric patients consistent with the indications for the aerosol medication. The Foshan Care Medical Nebulizer Compressor, Model KYWH2001, is not intended for life support nor does it provide any patient monitoring capabilities.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K101552 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101552: Foshan Care Medical Nebulizer Model KYWH2001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101552
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026