510(k) · Cleared
ClearedSiemens Sonoline SI-450, OB/Gyn,Ent,Dental Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Ultrasound, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Mar 21, 1991 after a 203-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 98 later devices descend from it.
- Decided
- Mar 21, 1991
- Review
- 203 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 0
98 later devices descend from it, 1 citing it directly.
- This deviceK904017 Siemens Sonoline SI-450, OB/Gyn,Ent,Dental DevicesSiemens Ultrasound, Inc. · 1991
- Descendant · cites it directly · 97 of its ownK060992 Syngo US WorkplaceSiemens Medical Solutions · 2006 · Recalled
- Descendant · 2 generations on · 95 of its ownK091286 Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 3 generations on · 92 of its ownK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
- Descendant · 4 generations on · 91 of its ownK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled
- Descendant · 5 generations on · 45 of its ownK171314 QLAB Advanced Quantification SoftwarePhilips Health Care · 2017
Showing 5 of 98 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 98 · See all- K060992Syngo US WorkplaceSiemens Medical Solutions · 2006 · cites it directly97descendants
- K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on95descendants
- K130159Qlab Quantification Software Heart ModelPhilips Health Care · 2013 · 3 generations on92descendants
- K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · 4 generations on91descendants
- K171314QLAB Advanced Quantification SoftwarePhilips Health Care · 2017 · 5 generations on45descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904017 | Siemens Sonoline SI-450, OB/Gyn,Ent,Dental Devices | Siemens Ultrasound, Inc. | 1991 | — |
| +1 | K060992 | Syngo US Workplace | Siemens Medical Solutions | 2006 | 1 |
| +2 | K091286 | Syngo US Workplace | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +3 | K130159 | Qlab Quantification Software Heart Model | Philips Health Care | 2013 | — |
| +4 | K132165 | Qlab Quantification Software | Philips Ultrasound, Inc. | 2013 | 1 |
| +5 | K171314 | QLAB Advanced Quantification Software | Philips Health Care | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 11 | 0 |
| 2021 | 7 | 0 |
| 2022 | 11 | 0 |
| 2023 | 8 | 0 |
| 2024 | 12 | 0 |
| 2025 | 17 | 0 |
| 2026 | 14 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (98)
See all 981 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060992 | Syngo US Workplace | 2006 | 97 |
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, K060992 (Siemens Medical Solutions, 2006) has gone furthest, with 97 descendants of its own.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
https://510kreport.com/device/K904017 · printed Nov 4, 2026
Cite this page
510(k) Report. “K904017: Siemens Sonoline SI-450, OB/Gyn,Ent,Dental Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904017
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026