510(k) · Cleared
ClearedCypress System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acuson Corp. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jun 27, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 995 devices in its family, counting itself, have a Class I recall. 994 later devices descend from it.
- Decided
- Jun 27, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
994 later devices descend from it, 4 citing it directly. 2 of the 995 devices in this family, counting this one, have a Class I recall.
- This deviceK010950 Cypress SystemAcuson Corp. · 2001
- Descendant · cites it directly · 930 of its ownK042593 Acuson Acunav 8F Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 2 generations on · 927 of its ownK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 926 of its ownK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · cites it directly · 898 of its ownK021497 Cypress Ultrasound SystemAcuson Corp. · 2002 · Recalled
- Descendant · 2 generations on · 827 of its ownK042055 Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
Showing 5 of 994 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 994 · See all- K042593Acuson Acunav 8F Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2004 · cites it directly930descendants
- K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on927descendants
- K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 3 generations on926descendants
- K021497Cypress Ultrasound SystemAcuson Corp. · 2002 · cites it directly898descendants
- K042055Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · 2 generations on827descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010950 | Cypress System | Acuson Corp. | 2001 | — |
| +1 | K042593 | Acuson Acunav 8F Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +2 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| +3 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| +1 | K021497 | Cypress Ultrasound System | Acuson Corp. | 2002 | 2 |
| +2 | K042055 | Cypress Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 9 | 0 |
| 2008 | 10 | 0 |
| 2009 | 16 | 0 |
| 2010 | 16 | 0 |
| 2011 | 29 | 0 |
| 2012 | 32 | 0 |
| 2013 | 45 | 0 |
| 2014 | 51 | 0 |
| 2015 | 57 | 0 |
| 2016 | 63 | 0 |
| 2017 | 78 | 0 |
| 2018 | 68 | 0 |
| 2019 | 50 | 0 |
| 2020 | 77 | 0 |
| 2021 | 55 | 0 |
| 2022 | 61 | 0 |
| 2023 | 59 | 0 |
| 2024 | 66 | 0 |
| 2025 | 83 | 2 |
| 2026 | 55 | 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.
2 devices in this family have 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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? (994)
See all 9944 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- Of its descendants, K042593 (Siemens Medical Solutions USA, Inc., 2004) has gone furthest, with 930 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
https://510kreport.com/device/K010950 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010950: Cypress System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010950
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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