510(k) · Cleared
ClearedNewport Nebsonic N550 Ultrasonic Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newport Medical Instruments, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Sep 7, 2004 as substantially equivalent to K960854 (Pacesetter, Inc., 1996) and 1 other predicate after a 134-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Sep 7, 2004
- Review
- 134 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K902859 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 1 generation backK990897 Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb…Puritan-Bennett Ireland, Ltd. · 2000 · Recalled
- This deviceK041082 Newport Nebsonic N550 Ultrasonic NebulizerNewport Medical Instruments, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −1 | K990897 | Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb Nebulizer | Puritan-Bennett Ireland, Ltd. | 2000 | 2 |
| 0 (this device) | K041082 | Newport Nebsonic N550 Ultrasonic Nebulizer | Newport Medical Instruments, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 |
|---|---|---|---|
| * | K960854 | Siemens Servo Ultra Nebulizer 345Summary page 2…ial Equivalence Sunnnary The NebSonic N550 Nebulizer is substantially equivalent to the Siemens Servo Ultra Nebulizer, Models 145 and 345, cleared under K960854, and the Puritan-Bennett EasyNeb Nebulizer, cleared as an accessory to the Puritan-Bennett 700 Series Ventilator… | 1996 |
| * | K990897 | Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb NebulizerSummary page 2…145 and 345, cleared under K960854, and the Puritan-Bennett EasyNeb Nebulizer, cleared as an accessory to the Puritan-Bennett 700 Series Ventilator under K990897. H. Device Testing The NebSonic N550 Nebulizer has been thoroughly evaluated at the unit and system level… | 2000 |
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 13 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K960854.
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?
The NebSonic N550 Nebulizer delivers nebulized medication for patients on mechanical ventilation or for patient use independent of a ventilator. The NebSonic is indicated for adult, pediatric, and neonatal patients
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041082 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041082: Newport Nebsonic N550 Ultrasonic Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041082
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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