510(k) · Cleared
ClearedUltrasonic Mesh Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Ivankaca Technology Co., Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jun 14, 2021 as substantially equivalent to K171549 (Qingdao Future Medical Technology Co., Ltd., 2018) after a 382-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- Jun 14, 2021
- Review
- 382 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K923024 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK923024 NE-U04/NE U04FOmron Healthcare, Inc. · 1992 · Recalled
- 3 generations backK062263 Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22Omron Healthcare, Inc. · 2007
- 2 generations backK132247 Ultrasonic Mesh NebulizerFoshan Gaunying Electronics Co., Ltd. · 2014
- 1 generation backK171549 Intelligent Mesh NebulizerQingdao Future Medical Technology Co., Ltd. · 2018
- This deviceK201397 Ultrasonic Mesh NebulizerShenzhen Ivankaca Technology Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK244035 Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K923024 | NE-U04/NE U04F | Omron Healthcare, Inc. | 1992 | 1 |
| −3 | K062263 | Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22 | Omron Healthcare, Inc. | 2007 | — |
| −2 | K132247 | Ultrasonic Mesh Nebulizer | Foshan Gaunying Electronics Co., Ltd. | 2014 | — |
| −1 | K171549 | Intelligent Mesh Nebulizer | Qingdao Future Medical Technology Co., Ltd. | 2018 | — |
| 0 (this device) | K201397 | Ultrasonic Mesh Nebulizer | Shenzhen Ivankaca Technology Co., Ltd. | 2021 | — |
| +1 | K244035 | Portable mesh nebulizer (JM821) | Shenzhen Jermei Medical Device Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K171549 | Intelligent Mesh NebulizerSummary page 5…Code CAF Regulation Class II Regulation Number 21 CFR 868.5630 4. Predicate device 510(k) Number： K171549 Predicate Device Name： Intelligent Mesh Nebulizer (model: NEB002) Manufacturer： Qingdao Future Medical Technology Co., Ltd This p… | 2018 |
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 |
|---|---|---|---|
| K244035 | Portable mesh nebulizer (JM821) | 2025 | 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 29 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K244035 (Shenzhen Jermei Medical Device Technology Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K171549.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Ultrasonic Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatric (>4 years of age), defined by the prescribed medication, and adult patients in the home, hospital and sub-acute care settings.
It is not intended for use with Pentamidine.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201397 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201397: Ultrasonic Mesh Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201397
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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