510(k) · Cleared
ClearedIntelligent Mesh Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qingdao Future Medical Technology Co., Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on Aug 31, 2018 as substantially equivalent to K062263 (Omron Healthcare, Inc., 2007) and 1 other predicate after a 462-day review. Its family tree reaches back 3 generations to 1992. 5 later devices descend from it.
- Decided
- Aug 31, 2018
- Review
- 462 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K923024 (1992). 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK923024 NE-U04/NE U04FOmron Healthcare, Inc. · 1992 · Recalled
- 2 generations backK062263 Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22Omron Healthcare, Inc. · 2007
- 1 generation backK132247 Ultrasonic Mesh NebulizerFoshan Gaunying Electronics Co., Ltd. · 2014
- This deviceK171549 Intelligent Mesh NebulizerQingdao Future Medical Technology Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK230379 Portable (Ultrasonic) NebulizerDongguan Simzo Electronic Technology Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK201397 Ultrasonic Mesh NebulizerShenzhen Ivankaca Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK254171 Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer…Shenzhen Mericonn Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK251659 Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK244035 Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd. · 2025
Most influential descendants
Showing 5 of 5 · See all- K230379Portable (Ultrasonic) NebulizerDongguan Simzo Electronic Technology Co., Ltd. · 2023 · cites it directly1descendant
- K201397Ultrasonic Mesh NebulizerShenzhen Ivankaca Technology Co., Ltd. · 2021 · cites it directly1descendant
- K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer…Shenzhen Mericonn Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd. · 2025 · cites it directly0descendants
- K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device 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 |
|---|---|---|---|---|---|
| −3 | K923024 | NE-U04/NE U04F | Omron Healthcare, Inc. | 1992 | 1 |
| −2 | K062263 | Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22 | Omron Healthcare, Inc. | 2007 | — |
| −1 | K132247 | Ultrasonic Mesh Nebulizer | Foshan Gaunying Electronics Co., Ltd. | 2014 | — |
| 0 (this device) | K171549 | Intelligent Mesh Nebulizer | Qingdao Future Medical Technology Co., Ltd. | 2018 | — |
| +1 | K230379 | Portable (Ultrasonic) Nebulizer | Dongguan Simzo Electronic Technology Co., Ltd. | 2023 | — |
| +1 | K201397 | Ultrasonic Mesh Nebulizer | Shenzhen Ivankaca Technology Co., Ltd. | 2021 | — |
| +2 | K254171 | Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh… | Shenzhen Mericonn Technology Co., Ltd. | 2026 | — |
| +1 | K251659 | Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. | 2025 | — |
| +2 | 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 |
|---|---|---|
| 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? (2)
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 7…system. Adapter Battery charging 6. Identification of Predicate Device Predicate Device #1: 510(k) Number K062263 Predicate Device Name Micro Air Vibrating Mesh Nebulizer (NE-U22) Manufacturer Omron Healthcare, Inc.… | 2007 |
| * | K132247 | Ultrasonic Mesh NebulizerSummary page 7…Predicate Device Name Micro Air Vibrating Mesh Nebulizer (NE-U22) Manufacturer Omron Healthcare, Inc. Predicate Device #2： 510(k) Number K132247 Predicate Device Name Ultrasonic Mesh Nebulizer NE105… | 2014 |
What descends from it? (5)
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?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K230379 (Dongguan Simzo Electronic Technology Co., Ltd., 2023) has gone furthest, with 1 descendant 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. 2018, 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 Intelligent Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatric (>4 years of age) and adult patients in the home, hospital and sub-acute care settings.
It is not intended for use with Pentamidine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171549: Intelligent 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/K171549
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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