510(k) · Cleared
ClearedHsiner Nebulizer Bottle, CPR Masks and Face Shields
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hsiner Co., Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on Aug 22, 2008 as substantially equivalent to K052811 (Hsiner Co., Ltd., 2005) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Aug 22, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K883964 (1988). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK883964 Airlife Misty Neb Medication System W/FilterBaxter Healthcare Corp · 1988
- 2 generations backK052811 Hsiner Jet Nebulizer, Model HS-31100Hsiner Co., Ltd. · 2005
- 1 generation backK070948 Hsiner Nebulizer BottleHsiner · 2007
- This deviceK082009 Hsiner Nebulizer Bottle, CPR Masks and Face ShieldsHsiner Co., Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883964 | Airlife Misty Neb Medication System W/Filter | Baxter Healthcare Corp | 1988 | — |
| −2 | K052811 | Hsiner Jet Nebulizer, Model HS-31100 | Hsiner Co., Ltd. | 2005 | — |
| −1 | K070948 | Hsiner Nebulizer Bottle | Hsiner | 2007 | — |
| 0 (this device) | K082009 | Hsiner Nebulizer Bottle, CPR Masks and Face Shields | Hsiner Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 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 |
|---|---|---|---|
| * | K052811 | Hsiner Jet Nebulizer, Model HS-31100 | 2005 |
| * | K070948 | Hsiner Nebulizer BottleSummary page 1…n Number: 868.5630 Device Class: 2 15.3. Substantially equivalent to: * Hsiner Jet Nebulizer (K05281 I) * Hsiner Bottle (K070948) 15.4. Description of the device The Hsiner's nebulizers are used to administer various aerosol treatments in both the homecare a… | 2007 |
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.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K052811.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Hsiner Nebulizer Bottle is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082009: Hsiner Nebulizer Bottle, CPR Masks and Face Shields.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082009
Report an extraction error
Are you the manufacturer?
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