510(k) · Cleared
ClearedAcuson P10 Diagnostic 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 Jan 4, 2007 as substantially equivalent to K052331 (Siemens Medical Solutions USA, Inc., 2005) and 3 other predicates after a 15-day review. Its family tree reaches back 7 generations to 1995. 2 of the 190 devices in its family, counting itself, have a Class I recall. 135 later devices descend from it.
- Decided
- Jan 4, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K935595 (1995). 54 ancestors in all, the oldest K891453 (1989). 135 later devices descend from it, 3 citing it directly. 2 of the 190 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 6 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 5 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 4 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 3 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 2 generations backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 1 generation backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- This deviceK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- Descendant · cites it directly · 130 of its ownK092756 GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS · 2009
- Descendant · cites it directly · 107 of its ownK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- Descendant · 2 generations on · 103 of its ownK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- Descendant · 3 generations on · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 79 of its ownK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled
Showing 5 of 135 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 135 · See all- K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS · 2009 · cites it directly130descendants
- K090505Speq Ultrasound SystemSignostics Pty, Ltd. · 2009 · cites it directly107descendants
- K102153Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011 · 2 generations on103descendants
- K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · 3 generations on87descendants
- K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · 4 generations on79descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −6 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −5 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −4 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −3 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −2 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −1 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| 0 (this device) | K063761 | Acuson P10 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +1 | K092756 | GE Vscan Compact Diagnostic Ultrasound System | Ge Vingmed Ultrasound AS | 2009 | — |
| +1 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
| +2 | K102153 | Mobius Ultrasound Imaging System | Mobisante, Inc. | 2011 | — |
| +3 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
| +4 | K152899 | Philips Lumify Diagnostic Ultrasound System | Philips Healthcare, Inc. | 2015 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 7 | 0 |
| 1998 | 3 | 0 |
| 1999 | 8 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 8 | 0 |
| 2019 | 6 | 0 |
| 2020 | 14 | 0 |
| 2021 | 13 | 0 |
| 2022 | 12 | 0 |
| 2023 | 9 | 0 |
| 2024 | 11 | 0 |
| 2025 | 19 | 2 |
| 2026 | 16 | 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? (4)
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 |
|---|---|---|---|
| * | K052331 | Acuson Cypress Ultrasound SystemSummary page 1…Product Code 90-IYO Diagnostic Ultrasound Transducer: FR # 892.1570 Product Code 90-ITX 3. Predicate Device: • K052331, 11/9/2005, ACUSON CypressrM Diagnostic Ultrasound System K052410, 9/22/2005, ACUSON Sequoia Tm Diagnostic Ultrasound… | 2005 |
| * | K052410 | Acuson Sequoia Ultrasound SystemSummary page 1…FR # 892.1570 Product Code 90-ITX 3. Predicate Device: • K052331, 11/9/2005, ACUSON CypressrM Diagnostic Ultrasound System K052410, 9/22/2005, ACUSON Sequoia Tm Diagnostic Ultrasound System •K020353, 2/13/2002, SONOLINE G50 & G60 S Diagnostic Ultraso… | 2005 |
| * | K020353 | Omnia X/XS Ultrasound SystemSummary page 1…: • K052331, 11/9/2005, ACUSON CypressrM Diagnostic Ultrasound System K052410, 9/22/2005, ACUSON Sequoia Tm Diagnostic Ultrasound System •K020353, 2/13/2002, SONOLINE G50 & G60 S Diagnostic Ultrasound System * K994096, 12/20/1 999, Sonosite SonoHeartTm Hand-Carried… | 2002 |
| * | K994096 | Sonoheart Hand-Carried Echocardiography SystemSummary page 1…K052410, 9/22/2005, ACUSON Sequoia Tm Diagnostic Ultrasound System •K020353, 2/13/2002, SONOLINE G50 & G60 S Diagnostic Ultrasound System * K994096, 12/20/1 999, Sonosite SonoHeartTm Hand-Carried Echocardiography System 4. Device Description: The ACUSON P1OTM is… | 1999 |
What descends from it? (135)
See all 1353 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 12 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 4 of the 54 ancestors have a recall of any class.
- Of its descendants, K092756 (Ge Vingmed Ultrasound AS, 2009) has gone furthest, with 130 descendants of its own.
- 1 other device also cites its predicate K052331.
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. 2007, this device’s year, is highlighted.
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:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063761 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063761: Acuson P10 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063761
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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