510(k) · Cleared
ClearedAcuson Model 2001
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 Oct 21, 1994 after a 371-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 1,097 devices in its family, counting itself, have a Class I recall. 1,096 later devices descend from it.
- Decided
- Oct 21, 1994
- Review
- 371 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 0
1,096 later devices descend from it, 2 citing it directly. 2 of the 1,097 devices in this family, counting this one, have a Class I recall.
- This deviceK934915 Acuson Model 2001Acuson Corp. · 1994
- Descendant · cites it directly · 1,093 of its ownK991805 Aspen Ultrasound with Freestyle Imaging OptionAcuson Corp. · 1999 · Recalled
- Descendant · 2 generations on · 1,069 of its ownK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- Descendant · 3 generations on · 1,003 of its ownK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- Descendant · 4 generations on · 988 of its ownK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 5 generations on · 979 of its ownK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
Showing 5 of 1,096 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 1,096 · See all- K991805Aspen Ultrasound with Freestyle Imaging OptionAcuson Corp. · 1999 · cites it directly1,093descendants
- K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002 · 2 generations on1,069descendants
- K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003 · 3 generations on1,003descendants
- K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · 4 generations on988descendants
- K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 5 generations on979descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934915 | Acuson Model 2001 | Acuson Corp. | 1994 | — |
| +1 | K991805 | Aspen Ultrasound with Freestyle Imaging Option | Acuson Corp. | 1999 | 1 |
| +2 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| +3 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +4 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +5 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2004 | 13 | 0 |
| 2005 | 14 | 0 |
| 2006 | 13 | 0 |
| 2007 | 18 | 0 |
| 2008 | 20 | 0 |
| 2009 | 23 | 0 |
| 2010 | 24 | 0 |
| 2011 | 34 | 0 |
| 2012 | 40 | 0 |
| 2013 | 45 | 0 |
| 2014 | 54 | 0 |
| 2015 | 62 | 0 |
| 2016 | 65 | 0 |
| 2017 | 78 | 0 |
| 2018 | 69 | 0 |
| 2019 | 50 | 0 |
| 2020 | 78 | 0 |
| 2021 | 56 | 0 |
| 2022 | 61 | 0 |
| 2023 | 61 | 0 |
| 2024 | 66 | 0 |
| 2025 | 86 | 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 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? (1,096)
See all 1,0962 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, K991805 (Acuson Corp., 1999) has gone furthest, with 1,093 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/K934915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934915: Acuson Model 2001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934915
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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