510(k) · Cleared

Cleared

Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22

K062263510(k) TraditionalCleared Feb 23, 2007203-day reviewClass II21 CFR 868.5630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Omron Healthcare, Inc. · CAF Nebulizer (Direct Patient Interface)

Cleared on Feb 23, 2007 as substantially equivalent to K923024 (Omron Healthcare, Inc., 1992) after a 203-day review. Its family tree reaches back 1 generation to 1992. 19 later devices descend from it.

Decided: Feb 23, 2007
Review: 203 days
Class: Class II
Product code: CAF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K923024 (1992). 19 later devices descend from it, 12 citing it directly.

By dateBy generation

Root · 1 generation backK923024 NE-U04/NE U04FOmron Healthcare, Inc. · 1992 · Recalled
This deviceK062263 Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22Omron Healthcare, Inc. · 2007
Descendant · cites it directly · 6 of its ownK132247 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 · cites it directly · 1 of its ownK202171 Pulmogine Vibrating Mesh NebulizerHcmed Innovations Co., Ltd. · 2021
Descendant · 2 generations on · 1 of its ownK201397 Ultrasonic Mesh NebulizerShenzhen Ivankaca Technology Co., Ltd. · 2021

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2008high 3 (2018) · low 0 (2010)2026

Most influential descendants

Showing 5 of 19 · See all

K132247Ultrasonic Mesh NebulizerFoshan Gaunying Electronics Co., Ltd. · 2014 · cites it directly6descendants
K171549Intelligent Mesh NebulizerQingdao Future Medical Technology Co., Ltd. · 2018 · cites it directly5descendants
K230379Portable (Ultrasonic) NebulizerDongguan Simzo Electronic Technology Co., Ltd. · 2023 · 2 generations on1descendant
K202171Pulmogine Vibrating Mesh NebulizerHcmed Innovations Co., Ltd. · 2021 · cites it directly1descendant
K201397Ultrasonic Mesh NebulizerShenzhen Ivankaca Technology Co., Ltd. · 2021 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923024	NE-U04/NE U04F	Omron Healthcare, Inc.	1992	1
0 (this device)	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	—
+1	K171549	Intelligent Mesh Nebulizer	Qingdao Future Medical Technology Co., Ltd.	2018	—
+2	K230379	Portable (Ultrasonic) Nebulizer	Dongguan Simzo Electronic Technology Co., Ltd.	2023	—
+1	K202171	Pulmogine Vibrating Mesh Nebulizer	Hcmed Innovations Co., Ltd.	2021	—
+2	K201397	Ultrasonic Mesh Nebulizer	Shenzhen Ivankaca Technology Co., Ltd.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2011	1	0
2012	1	0
2013	2	0
2014	2	0
2017	1	0
2018	3	0
2021	2	0
2023	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K062263, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K923024	NE-U04/NE U04F Summary page 1 …Nebulizer (Direct Patient Interface) Device: Model NE-U22 Predicate Devices: Omron - NE-LJO4 K923 024 IDevice Description: Micro Air Vibrating Mesh Nebulizer (NE-U22) uses low frequency vibration to create aerosol and provide fin…	Omron Healthcare, Inc.	1992	1

Also cleared against K923024: 2 other devices →

What descends from it? (19)

See all 19

12 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K132247	Ultrasonic Mesh Nebulizer	Foshan Gaunying Electronics Co., Ltd.	2014	6
K171549	Intelligent Mesh Nebulizer	Qingdao Future Medical Technology Co., Ltd.	2018	5
K202171	Pulmogine Vibrating Mesh Nebulizer	Hcmed Innovations Co., Ltd.	2021	1
K170916	Portable Nebulizer	Microbase Technology Corporation	2017	1
K081738	Ultrasonic Nebulizer System, Model HL100	Health & Life Co., Ltd.	2008	1
K170886	HOMED Mesh Nebulizer	Shenzhen Homed Medical Device Co., Ltd.	2018	0
K133105	Breeze Nebulizer (NBR-10X)	Digio2 International Co., Ltd.	2014	0
K122060	Clever TD-7001NEBULIZER	Taidoc Technology Corporation	2013	0
K121520	Ultrasonic Nebulizer (Mesh Type)	K-Jump Health Co., Ltd.	2013	0
K121154	Ultrasonic Nebulizer	Foshan Gaunying Electronics Co., Ltd.	2012	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?

Its one ancestor has a recall.
Of its descendants, K132247 (Foshan Gaunying Electronics Co., Ltd., 2014) has gone furthest, with 6 descendants of its own.
2 other devices also cite its predicate K923024.

How does its category compare?

All CAF devices

CAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · CAF

7in 2025

2007high 18 (2007) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAF

211in 2025

2007high 324 (2021) · low 98 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CAF

1in 2018

2007high 14 (2017) · low 0 (2008)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · CAF

191in 2025

2007high 256 (2017) · low 11 (2008)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 Omron NE-U22 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medications for inhalation by the patient.

The device may be used with pediatric 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/K062263 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062263: Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062263

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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