510(k) · Cleared
ClearedDdi Ultrasonic Nebulizer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Devices, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jun 18, 2009 as substantially equivalent to K062263 (Omron Healthcare, Inc., 2007) and 1 other predicate after a 132-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Jun 18, 2009
- Review
- 132 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K923024 (1992). No later device cites it as a predicate yet.
- 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 backK081738 Ultrasonic Nebulizer System, Model HL100Health & Life Co., Ltd. · 2008
- This deviceK090307 Ddi Ultrasonic Nebulizer SystemDiagnostic Devices, Inc. · 2009
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 | K081738 | Ultrasonic Nebulizer System, Model HL100 | Health & Life Co., Ltd. | 2008 | — |
| 0 (this device) | K090307 | Ddi Ultrasonic Nebulizer System | Diagnostic Devices, Inc. | 2009 | — |
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 1…ted Equivalent Device Company Product Si10(k) I Omron Healthcare Inc. Micro Air Vibrating Mesh Nebulizer K062263 Health & Life Co., Ltd. Ultrasonic Nebulizer System Model HL 100 K08173 8 DEVICE DESCRIPTION… | 2007 |
| * | K081738 | Ultrasonic Nebulizer System, Model HL100Summary page 1…Si10(k) I Omron Healthcare Inc. Micro Air Vibrating Mesh Nebulizer K062263 Health & Life Co., Ltd. Ultrasonic Nebulizer System Model HL 100 K08173 8 DEVICE DESCRIPTION 807.92(a)(4) The DDI Ultrasonic Nebulizer System is a mesh… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 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. 2009, 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 DDI Ultrasonic Nebulizer System is an ultrasonic (vibrating mesh) nebulizer system
designed to aerosolize 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090307: Ddi Ultrasonic Nebulizer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090307
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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