510(k) · Cleared
Recalled · 2004Cypress Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acuson Corp. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jul 9, 2002 as substantially equivalent to K010950 (Acuson Corp., 2001) and 2 other predicates after a 61-day review. Its family tree reaches back 3 generations to 1994. 2 of the 906 devices in its family, counting itself, have a Class I recall. 898 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 9, 2002
- Review
- 61 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K934041 (1994). 7 ancestors in all, the oldest K891689 (1989). 898 later devices descend from it, 5 citing it directly. 2 of the 906 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
- 2 generations backK964309 Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997
- 1 generation backK982800 Ecton Lynx Ultrasound SystemEcton, Inc. · 1998
- This deviceK021497 Cypress Ultrasound SystemAcuson Corp. · 2002
- Descendant · cites it directly · 827 of its ownK042055 Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 2 generations on · 806 of its ownK052021 V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 802 of its ownK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- Descendant · 4 generations on · 801 of its ownK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- Descendant · 5 generations on · 800 of its ownK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
Showing 5 of 898 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 898 · See all- K042055Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · cites it directly827descendants
- K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on806descendants
- K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 3 generations on802descendants
- K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · 4 generations on801descendants
- K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · 5 generations on800descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934041 | Hewlett Packard Conos Ultrasound Imaging System Modification | Hewlett-Packard Co. | 1994 | — |
| −2 | K964309 | Sonos 2000, Sonos 2500 (M2406 a) | Hewlett-Packard Co. | 1997 | — |
| −1 | K982800 | Ecton Lynx Ultrasound System | Ecton, Inc. | 1998 | — |
| 0 (this device) | K021497 | Cypress Ultrasound System | Acuson Corp. | 2002 | — |
| +1 | K042055 | Cypress Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +2 | K052021 | V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| +3 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +4 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| +5 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 9 | 0 |
| 2010 | 10 | 0 |
| 2011 | 22 | 0 |
| 2012 | 29 | 0 |
| 2013 | 38 | 0 |
| 2014 | 51 | 0 |
| 2015 | 53 | 0 |
| 2016 | 63 | 0 |
| 2017 | 74 | 0 |
| 2018 | 65 | 0 |
| 2019 | 49 | 0 |
| 2020 | 72 | 0 |
| 2021 | 51 | 0 |
| 2022 | 59 | 0 |
| 2023 | 54 | 0 |
| 2024 | 57 | 0 |
| 2025 | 75 | 2 |
| 2026 | 51 | 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? (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 |
|---|---|---|---|
| * | K010950 | Cypress SystemSummary page 1…rasonic Pulsed Echo Imaging System (90 IYO), class II (21 C.F.R. $892.1560) Diagnostic Ultrasound Transducer (90 ITX), class II (21 C.F.R. $892.1570) Predicate Devices: K010950,6/27/2001, cleared as the Acuson Cypress Ultrasound System. K982800, 9/22/98, cleared as the Ecton Lynx Ultrasound System, marke… | 2001 |
| * | K982800 | Ecton Lynx Ultrasound SystemSummary page 1….1560) Diagnostic Ultrasound Transducer (90 ITX), class II (21 C.F.R. $892.1570) Predicate Devices: K010950,6/27/2001, cleared as the Acuson Cypress Ultrasound System. K982800, 9/22/98, cleared as the Ecton Lynx Ultrasound System, marketed as the Acuson Cypress Ultrasound System with subsequent modificat… | 1998 |
| * | K991872 | Lynx Ultrasound SystemSummary page 1…press Ultrasound System. K982800, 9/22/98, cleared as the Ecton Lynx Ultrasound System, marketed as the Acuson Cypress Ultrasound System with subsequent modifications. K99 1872, 6/16/99, cleared as Ecton Lynx Ultrasound System, marketed Acuson Cypress Ultrasound System with subsequent modifications. Dev… | 1999 |
What descends from it? (898)
See all 8985 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 2, 2004 | Not classified | Z-0744-04 | Other | software problem - mode does not appear on screen |
| Apr 1, 2003 | Not classified | Z-0975-03 | Other | software problem - loss of data |
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 8 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K042055 (Siemens Medical Solutions USA, Inc., 2004) has gone furthest, with 827 descendants of its own.
- 3 other devices also cite its predicate K010950.
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 ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021497: 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/K021497
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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