510(k) · Cleared
ClearedNebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Homed Medical Device Co., Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on Mar 25, 2022 as substantially equivalent to K091272 (Besmed Health Business Corp, 2009) after a 235-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Mar 25, 2022
- Review
- 235 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
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 backK091272 Besmed Jet Nebulizer Bottle SetBesmed Health Business Corp · 2009 · Recalled
- This deviceK212395 NebulizerShenzhen Homed Medical Device Co., Ltd. · 2022
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 | K091272 | Besmed Jet Nebulizer Bottle Set | Besmed Health Business Corp | 2009 | 1 |
| 0 (this device) | K212395 | Nebulizer | Shenzhen Homed Medical Device Co., Ltd. | 2022 | — |
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? (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 |
|---|---|---|---|
| * | K091272 | Besmed Jet Nebulizer Bottle SetSummary page 4…egulation Number: 868.5630 3. Predicate Device Information Trade Name BESMED Jet Nebulizer Bottle Set 510(k) Number K091272 Classification name Nebulizer Classification: II Review Panel: Anesthesiology… | 2009 |
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 34 years and passes through 4 companies; a new generation was cleared every 12.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 JLI nebulizer is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and healthcare settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer. The JLI nebulizer is disposable, single-patient-use and intended for use with pediatric (5 years and older) and adult patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212395: Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212395
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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