510(k) · Cleared
ClearedUltraneb
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bremed Italia, S.R.L. · CAF Nebulizer (Direct Patient Interface)
Cleared on Feb 18, 1998 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Feb 18, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK974379 UltranebBremed Italia, S.R.L. · 1998
- Descendant · cites it directly · 0 of its ownK083256 Ultrasonic Nebulizer System, Model KN-9210K-Jump Health Co., Ltd. · 2009
Most influential descendants
Showing 1 of 1 · See all- K083256Ultrasonic Nebulizer System, Model KN-9210K-Jump Health Co., Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974379 | Ultraneb | Bremed Italia, S.R.L. | 1998 | — |
| +1 | K083256 | Ultrasonic Nebulizer System, Model KN-9210 | K-Jump Health Co., Ltd. | 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K083256 | Ultrasonic Nebulizer System, Model KN-9210 | 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?
- Of its descendants, K083256 (K-Jump Health Co., Ltd., 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
This product is an ultrasonic ncbulizcr that is used to provide acrosolized broncho dialator medication 1o persons with asthma and cmphysema. The device creates acrosolized particles of the prescribed medication via ultrasound that is forced via a vacuum or draw into disposable tubing. The acrosolized medication travels up the tubing and into either a nasal or oral mask. The paticent then inhales the medication as per his/her physician's orders. This…
Read the full statement (169 words)
This product is an ultrasonic ncbulizcr that is used to provide acrosolized broncho dialator medication 1o persons with asthma and cmphysema. The device creates acrosolized particles of the prescribed medication via ultrasound that is forced via a vacuum or draw into disposable tubing. The acrosolized medication travels up the tubing and into either a nasal or oral mask. The paticent then inhales the medication as per his/her physician's orders.
This product contains the exact same technological characteristics of similar devices currcntly on the market. The product functions cxactly as these similar devices.
The product is designed with similar performance characteristics as devices currently on the market. The performance of the device allows it to be used in conjunction with various nasal and oral masks that arc currently in distribution in the United States and Europc.
The components found within this product are common items. The product consists of a thermally protccted. simplistic circuit board. a piczcoelectric ceramic. a medicine cup. an ABS plastic casc. a switch. an ¢lectrical cord.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974379 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974379: Ultraneb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974379
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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