510(k) · Cleared
ClearedCypress Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 16, 2004 as substantially equivalent to K021497 (Acuson Corp., 2002) and 1 other predicate after a 17-day review. Its family tree reaches back 4 generations to 1994. 2 of the 849 devices in its family, counting itself, have a Class I recall. 827 later devices descend from it.
- Decided
- Aug 16, 2004
- Review
- 17 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K934041 (1994). 21 ancestors in all, the oldest K891689 (1989). 827 later devices descend from it, 2 citing it directly. 2 of the 849 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
- 3 generations backK964309 Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997
- 2 generations backK982800 Ecton Lynx Ultrasound SystemEcton, Inc. · 1998
- 1 generation backK021497 Cypress Ultrasound SystemAcuson Corp. · 2002 · Recalled
- This deviceK042055 Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- Descendant · cites it directly · 806 of its ownK052021 V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 802 of its ownK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- Descendant · 3 generations on · 801 of its ownK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- Descendant · 4 generations on · 800 of its ownK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 5 generations on · 588 of its ownK093563 IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · Recalled
Showing 5 of 827 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 827 · See all- K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · cites it directly806descendants
- K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 2 generations on802descendants
- K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · 3 generations on801descendants
- K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · 4 generations on800descendants
- K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · 5 generations on588descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K934041 | Hewlett Packard Conos Ultrasound Imaging System Modification | Hewlett-Packard Co. | 1994 | — |
| −3 | K964309 | Sonos 2000, Sonos 2500 (M2406 a) | Hewlett-Packard Co. | 1997 | — |
| −2 | K982800 | Ecton Lynx Ultrasound System | Ecton, Inc. | 1998 | — |
| −1 | K021497 | Cypress Ultrasound System | Acuson Corp. | 2002 | 2 |
| 0 (this device) | K042055 | Cypress Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +1 | K052021 | V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| +2 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +3 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| +4 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +5 | K093563 | IU22 Ultrasound System and Transducers | Philips Ultrasound, Inc. | 2010 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 7 | 0 |
| 2010 | 10 | 0 |
| 2011 | 19 | 0 |
| 2012 | 28 | 0 |
| 2013 | 33 | 0 |
| 2014 | 47 | 0 |
| 2015 | 52 | 0 |
| 2016 | 58 | 0 |
| 2017 | 71 | 0 |
| 2018 | 63 | 0 |
| 2019 | 46 | 0 |
| 2020 | 65 | 0 |
| 2021 | 48 | 0 |
| 2022 | 54 | 0 |
| 2023 | 50 | 0 |
| 2024 | 54 | 0 |
| 2025 | 65 | 2 |
| 2026 | 47 | 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.
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 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? (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 |
|---|---|---|---|
| * | K021497 | Cypress Ultrasound SystemSummary page 1…892.1570 90-VFX Diagnostic Intravascular Catheter 870.1200 90-DQO Predicate Devices: *# K02 1497 (July 9, 2002) cleared as ACUSON CypressTMd Ultrasound System. *# K0321 14 (July 21, 2003) cleared as ACUSON Sequoia TM Diag… | 2002 |
| * | K032114 | Sequoia 8.0 Diagnostic Ultrasound SystemSummary page 1…870.1200 90-DQO Predicate Devices: *# K02 1497 (July 9, 2002) cleared as ACUSON CypressTMd Ultrasound System. *# K0321 14 (July 21, 2003) cleared as ACUSON Sequoia TM Diagnostic Ultrasound System. Section I I 510(… | 2003 |
What descends from it? (827)
See all 8272 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?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K052021 (Siemens Medical Solutions USA, Inc., 2005) has gone furthest, with 806 descendants of its own.
- 4 other devices also cite its predicate K021497.
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) | — |
What is it indicated for?
Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: For intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - use in right heart…
Read the full statement (207 words)
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
For intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - use in right heart only.
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
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/K042055 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042055: Cypress Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042055
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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