510(k) · Cleared
ClearedVentripoint Medical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventripoint, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Mar 6, 2014 as substantially equivalent to K102017 (Siemens Medical Solutions USA, Inc., 2010) and 1 other predicate after a 43-day review. Its family tree reaches back 10 generations to 1995. 2 later devices descend from it.
- Decided
- Mar 6, 2014
- Review
- 43 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K935595 (1995). 27 ancestors in all, the oldest K921148 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 6 generations between
- 3 generations backK063085 Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK072365 Sequoia Plus Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 1 generation backK102017 SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2010 · Recalled
- This deviceK140153 Ventripoint Medical SystemVentripoint, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK150628 VentriPoint Medical SystemVentripoint, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK173810 Ventripoint Medical System Plus (VMS+)Ventripoint Diagnostics, Ltd. · 2018
Show all 10 generations
- Root · 10 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 8 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 7 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 6 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 5 generations backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 4 generations backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 3 generations backK063085 Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK072365 Sequoia Plus Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 1 generation backK102017 SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2010 · Recalled
- This deviceK140153 Ventripoint Medical SystemVentripoint, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −9 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −8 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −7 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −6 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −5 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −4 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −3 | K063085 | Modification to Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −2 | K072365 | Sequoia Plus Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 3 |
| −1 | K102017 | SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2010 | 1 |
| 0 (this device) | K140153 | Ventripoint Medical System | Ventripoint, Inc. | 2014 | — |
| +1 | K150628 | VentriPoint Medical System | Ventripoint, Inc. | 2015 | — |
| +2 | K173810 | Ventripoint Medical System Plus (VMS+) | Ventripoint Diagnostics, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 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.
Planning a device in IYN? 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 |
|---|---|---|---|
| * | K102017 | SC2000 Diagnostic Ultrasound SystemSummary page 1…807.92(a)(3) Legally Marketed Equivalent Device 510(k) # Product Companly K102017 Acuson SC2000TM Ultrasound System Siemens Medical Solutions. Inc K963807 Echo-Scan with Freehand Scannin… | 2010 |
| * | K963807 | Tomtec Echo-ScanSummary page 1…ce 510(k) # Product Companly K102017 Acuson SC2000TM Ultrasound System Siemens Medical Solutions. Inc K963807 Echo-Scan with Freehand Scanning Tomn'ec Imaging Systems GmbH DEVICE I)ESCRIPTION… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150628 | VentriPoint Medical System | 2015 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 27 ancestors have a recall of any class.
- Of its descendants, K150628 (Ventripoint, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K102017.
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. 2014, 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?
The VMS system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. The VMS system is used to record a sequence of conventional cardiac 2-D ultrasound images with the transducer position recorded for each image acquired to compute right ventricular volumes and ejection fraction. Specific anatomic landmarks identified by the…
Read the full statement (119 words)
The VMS system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. The VMS system is used to record a sequence of conventional cardiac 2-D ultrasound images with the transducer position recorded for each image acquired to compute right ventricular volumes and ejection fraction. Specific anatomic landmarks identified by the product user are transmitted by secure internet connection to a VMS server where 3-D assembly of the right ventricle in adult patients with Pulmonary Arterial Hypertension takes place using Knowledge Based Reconstruction (KBR). The results are then returned to the VMS system for display and further consideration or evaluation by the product user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140153 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140153: Ventripoint Medical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140153
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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