510(k) · Cleared
ClearedUltrasonic Nebulizer System, Model HL100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health & Life Co., Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on Sep 17, 2008 as substantially equivalent to K062263 (Omron Healthcare, Inc., 2007) after a 90-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Sep 17, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923024 (1992). 1 later device descends 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 deviceK081738 Ultrasonic Nebulizer System, Model HL100Health & Life Co., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK090307 Ddi Ultrasonic Nebulizer SystemDiagnostic Devices, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K090307Ddi Ultrasonic Nebulizer SystemDiagnostic Devices, Inc. · 2009 · cites it directly0descendants
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) | K081738 | Ultrasonic Nebulizer System, Model HL100 | Health & Life Co., Ltd. | 2008 | — |
| +1 | K090307 | Ddi Ultrasonic Nebulizer System | Diagnostic Devices, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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…Code: 73 CAF C.F.R. Section: Classification Panel: Anesthesiology 3.0 PREDICATE DEVICE Ornron Model NE-U22V MircroAir Nebulizer (K062263) 4.0 DEVICE DESCRIPTION The Health and Life Model HLIOO is a mesh screen ultrasonic nebulizer that operates in an… | 2007 |
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 |
|---|---|---|---|
| K090307 | Ddi Ultrasonic Nebulizer System | 2009 | 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 16 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, K090307 (Diagnostic Devices, Inc., 2009) has gone furthest, with 0 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. 2008, 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 HL100 Ultrasonic Nebulizer System utillizes the
state-of-the-art elecctrospray technology that sprays liquid medication in aerosol
form and deliveries it directly to the adult and pediatric patients who suffer from
asthma, Chronic Obstructive Pulmonary Disease (COPD) such as emphysema
and chronic bronchitis, or other respiratory diseases that are characterized by
obstruction to air flow for breathing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081738: Ultrasonic Nebulizer System, Model HL100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081738
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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