510(k) · Cleared
ClearedHsiner Jet Nebulizer, Model HS-31100
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 Dec 21, 2005 as substantially equivalent to K883964 (Baxter Healthcare Corp, 1988) and 2 other predicates after a 78-day review. Its family tree reaches back 1 generation to 1988. 4 later devices descend from it.
- Decided
- Dec 21, 2005
- Review
- 78 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K883964 (1988). 3 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK883964 Airlife Misty Neb Medication System W/FilterBaxter Healthcare Corp · 1988
- This deviceK052811 Hsiner Jet Nebulizer, Model HS-31100Hsiner Co., Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK091272 Besmed Jet Nebulizer Bottle SetBesmed Health Business Corp · 2009 · Recalled
- Descendant · cites it directly · 1 of its ownK070948 Hsiner Nebulizer BottleHsiner · 2007
- Descendant · 2 generations on · 0 of its ownK212395 NebulizerShenzhen Homed Medical Device Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK082009 Hsiner Nebulizer Bottle, CPR Masks and Face ShieldsHsiner Co., Ltd. · 2008
Most influential descendants
Showing 4 of 4 · See all- K091272Besmed Jet Nebulizer Bottle SetBesmed Health Business Corp · 2009 · cites it directly1descendant
- K070948Hsiner Nebulizer BottleHsiner · 2007 · cites it directly1descendant
- K212395NebulizerShenzhen Homed Medical Device Co., Ltd. · 2022 · 2 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| −1 | K883964 | Airlife Misty Neb Medication System W/Filter | Baxter Healthcare Corp | 1988 | — |
| 0 (this device) | K052811 | Hsiner Jet Nebulizer, Model HS-31100 | Hsiner Co., Ltd. | 2005 | — |
| +1 | K091272 | Besmed Jet Nebulizer Bottle Set | Besmed Health Business Corp | 2009 | 1 |
| +1 | K070948 | Hsiner Nebulizer Bottle | Hsiner | 2007 | — |
| +2 | K212395 | Nebulizer | Shenzhen Homed Medical Device Co., Ltd. | 2022 | — |
| +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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K883964 | Airlife Misty Neb Medication System W/FilterSummary page 1…CAY Regulation Number: 868.5630 Device Class 2 8.4. Substantially equivalent to: • Allegiance Misty-Neb (K883964). • Salter Labs Nebulizer (K(884947) • Hudson RCI Micro Mist (K(930525) 8.5. Description of the device… | 1988 |
| * | K884947 | Hand Held Nebulizer SystemSummary page 1…5630 Device Class 2 8.4. Substantially equivalent to: • Allegiance Misty-Neb (K883964). • Salter Labs Nebulizer (K(884947) • Hudson RCI Micro Mist (K(930525) 8.5. Description of the device The Hsiner Jet Nebulizer is used to administer… | 1989 |
| * | K930525 | Micro Mist (TM) NebulizerSummary page 1…8.4. Substantially equivalent to: • Allegiance Misty-Neb (K883964). • Salter Labs Nebulizer (K(884947) • Hudson RCI Micro Mist (K(930525) 8.5. Description of the device The Hsiner Jet Nebulizer is used to administer various aerosol treatments in both the homeca… | 1993 |
What descends from it? (4)
3 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?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K091272 (Besmed Health Business Corp, 2009) has gone furthest, with 1 descendant 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?
The Hsiner Jet Nebulizer 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/K052811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052811: Hsiner Jet Nebulizer, Model HS-31100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052811
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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