510(k) · Cleared
ClearedUltrasonic Mesh Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foshan Gaunying Electronics Co., Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jan 8, 2014 as substantially equivalent to K062263 (Omron Healthcare, Inc., 2007) after a 173-day review. Its family tree reaches back 2 generations to 1992. 6 later devices descend from it.
- Decided
- Jan 8, 2014
- Review
- 173 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923024 (1992). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK923024 NE-U04/NE U04FOmron Healthcare, Inc. · 1992 · Recalled
- 1 generation backK062263 Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22Omron Healthcare, Inc. · 2007
- This deviceK132247 Ultrasonic Mesh NebulizerFoshan Gaunying Electronics Co., Ltd. · 2014
- Descendant · cites it directly · 5 of its ownK171549 Intelligent Mesh NebulizerQingdao Future Medical Technology Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK230379 Portable (Ultrasonic) NebulizerDongguan Simzo Electronic Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK201397 Ultrasonic Mesh NebulizerShenzhen Ivankaca Technology Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK254171 Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer…Shenzhen Mericonn Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251659 Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K171549Intelligent Mesh NebulizerQingdao Future Medical Technology Co., Ltd. · 2018 · cites it directly5descendants
- K230379Portable (Ultrasonic) NebulizerDongguan Simzo Electronic Technology Co., Ltd. · 2023 · 2 generations on1descendant
- K201397Ultrasonic Mesh NebulizerShenzhen Ivankaca Technology Co., Ltd. · 2021 · 2 generations on1descendant
- K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer…Shenzhen Mericonn Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923024 | NE-U04/NE U04F | Omron Healthcare, Inc. | 1992 | 1 |
| −1 | K062263 | Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22 | Omron Healthcare, Inc. | 2007 | — |
| 0 (this device) | K132247 | Ultrasonic Mesh Nebulizer | Foshan Gaunying Electronics Co., Ltd. | 2014 | — |
| +1 | K171549 | Intelligent Mesh Nebulizer | Qingdao Future Medical Technology Co., Ltd. | 2018 | — |
| +2 | K230379 | Portable (Ultrasonic) Nebulizer | Dongguan Simzo Electronic Technology Co., Ltd. | 2023 | — |
| +2 | K201397 | Ultrasonic Mesh Nebulizer | Shenzhen Ivankaca Technology Co., Ltd. | 2021 | — |
| +3 | K254171 | Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh… | Shenzhen Mericonn Technology Co., Ltd. | 2026 | — |
| +2 | K251659 | Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K062263 | Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22Summary page 1…Device Class: 11 3. Predicate (cleared) Device: Predicate Device: Micro Air Vibrating Mesh Nebulizer NE-U22 5 10O(k) Number: K062263 Manufacturer: Omtron Healthcare Inc. 4. Description of Proposed Device: The Ultrasonic Mesh Nebuli… | 2007 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171549 | Intelligent Mesh Nebulizer | 2018 | 5 |
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 22 years and passes through 2 companies; a new generation was cleared every 14.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K171549 (Qingdao Future Medical Technology Co., Ltd., 2018) has gone furthest, with 5 descendants of its own.
- 11 other devices also cite its predicate K062263.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 model NE105 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult and pediatric patients at the discretion of their physician at home, hospital & sub-acute care setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132247 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132247: Ultrasonic Mesh Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132247
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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