510(k) · Cleared
ClearedSiemens Servo Ultra Nebulizer 345
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pacesetter, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Dec 23, 1996 after a 297-day review. The FDA summary names its predicate without a number. 1 of the 5 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Dec 23, 1996
- Review
- 297 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- This deviceK960854 Siemens Servo Ultra Nebulizer 345Pacesetter, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK990897 Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb…Puritan-Bennett Ireland, Ltd. · 2000 · Recalled
- Descendant · cites it directly · 0 of its ownK041082 Newport Nebsonic N550 Ultrasonic NebulizerNewport Medical Instruments, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK020357 800 Series Easyneb NebulizerNellcor Puritan Bennett, Inc. · 2002 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK021175 Aeroneb Professional Nebulizer System, Model#AG-AP6000Aerogen, Inc. · 2002 · Recalled
Class I recalls in this family
- K020357 800 Series Easyneb Nebulizer2 generations on · 2002
Most influential descendants
Showing 4 of 4 · See all- K990897Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb NebulizerPuritan-Bennett Ireland, Ltd. · 2000 · cites it directly2descendants
- K041082Newport Nebsonic N550 Ultrasonic NebulizerNewport Medical Instruments, Inc. · 2004 · cites it directly0descendants
- K020357800 Series Easyneb NebulizerNellcor Puritan Bennett, Inc. · 2002 · 2 generations on0descendants
- K021175Aeroneb Professional Nebulizer System, Model#AG-AP6000Aerogen, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960854 | Siemens Servo Ultra Nebulizer 345 | Pacesetter, Inc. | 1996 | — |
| +1 | K990897 | Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb Nebulizer | Puritan-Bennett Ireland, Ltd. | 2000 | 2 |
| +1 | K041082 | Newport Nebsonic N550 Ultrasonic Nebulizer | Newport Medical Instruments, Inc. | 2004 | — |
| +2 | K020357 | 800 Series Easyneb Nebulizer | Nellcor Puritan Bennett, Inc. | 2002 | Class I |
| +1 | K021175 | Aeroneb Professional Nebulizer System, Model#AG-AP6000 | Aerogen, Inc. | 2002 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 2 | 1 |
| 2004 | 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.
1 device in this family has a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | — | Microsonic Ultrasonic Nebulizer Named without a submission number | |
| * | — | Omron NE-UO7 Ultra-Air Named without a submission number | |
| * | — | Siemens Servo Nebulizer 945 Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K020357800 Series Easyneb NebulizerNellcor Puritan Bennett, Inc. · 2002 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K990897 (Puritan-Bennett Ireland, Ltd., 2000) has gone furthest, with 2 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?
The intended use of the Siemens Model 345 Ultra Nebulizer is to nebulize liquid medication for introduction into the patient’s airway via an endotracheal tube. It can be used on any patient for whom the use of the Siemens Servo Ventilator 300 is indicated, in any ventilatory mode appropriate for the patient.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960854 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960854: Siemens Servo Ultra Nebulizer 345.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960854
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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