510(k) · Cleared
ClearedHsiner Nebulizer Bottle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hsiner · CAF Nebulizer (Direct Patient Interface)
Cleared on Apr 25, 2007 as substantially equivalent to K052811 (Hsiner Co., Ltd., 2005) after a 21-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Apr 25, 2007
- Review
- 21 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K883964 (1988). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK883964 Airlife Misty Neb Medication System W/FilterBaxter Healthcare Corp · 1988
- 1 generation backK052811 Hsiner Jet Nebulizer, Model HS-31100Hsiner Co., Ltd. · 2005
- This deviceK070948 Hsiner Nebulizer BottleHsiner · 2007
- Descendant · cites it directly · 0 of its ownK082009 Hsiner Nebulizer Bottle, CPR Masks and Face ShieldsHsiner Co., Ltd. · 2008
Most influential descendants
Showing 1 of 1 · See all- K082009Hsiner Nebulizer Bottle, CPR Masks and Face ShieldsHsiner Co., Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883964 | Airlife Misty Neb Medication System W/Filter | Baxter Healthcare Corp | 1988 | — |
| −1 | K052811 | Hsiner Jet Nebulizer, Model HS-31100 | Hsiner Co., Ltd. | 2005 | — |
| 0 (this device) | K070948 | Hsiner Nebulizer Bottle | Hsiner | 2007 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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-31100Summary page 1…t Code: CAF Regulation Number: 868.5630 Device Class 2 6.3. Substantially equivalent to: * Hsiner Jet Nebulizer (K052811) 6.4. Description of the device The Hsiner Nebulizer Bottle is used to administer various aerosol treatments in both the home… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082009 | Hsiner Nebulizer Bottle, CPR Masks and Face Shields | 2008 | 0 |
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 19 years and passes through 3 companies; a new generation was cleared every 17.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K082009 (Hsiner Co., Ltd., 2008) has gone furthest, with 0 descendants of its own.
- 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. 2007, 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/K070948 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070948: Hsiner Nebulizer Bottle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070948
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