510(k) · Cleared
ClearedGE Voluson I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Dec 16, 2005 as substantially equivalent to K003525 (Medison America, Inc., 2000) and 2 other predicates after a 7-day review. Its family tree reaches back 3 generations to 2000. 407 later devices descend from it.
- Decided
- Dec 16, 2005
- Review
- 7 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K003525 (2000). 407 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK003525 Voluson 730 Diagnostic Ultrasound SystemMedison America, Inc. · 2000
- 2 generations backK032620 GE Voluson 730 Pro/Expert BT03 Ultrasound SystemGeneral Electric Co. · 2003
- 1 generation backK041688 GE Voluson 730 Pro/Expert Untrasound BT04General Electric Co. · 2004 · Recalled
- This deviceK053435 GE Voluson IGeneral Electric Co. · 2005
- Descendant · cites it directly · 296 of its ownK103649 Voluson S6, Voluson S8GE Healthcare · 2011
- Descendant · cites it directly · 295 of its ownK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- Descendant · 2 generations on · 270 of its ownK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- Descendant · 3 generations on · 255 of its ownK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- Descendant · 2 generations on · 201 of its ownK122387 Voluson P6, Voluson P8GE Healthcare · 2012
Showing 5 of 407 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 407 · See all- K103649Voluson S6, Voluson S8GE Healthcare · 2011 · cites it directly296descendants
- K120741Voluson S6, Voluson S8GE Healthcare · 2012 · cites it directly295descendants
- K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013 · 2 generations on270descendants
- K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013 · 3 generations on255descendants
- K122387Voluson P6, Voluson P8GE Healthcare · 2012 · 2 generations on201descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003525 | Voluson 730 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | — |
| −2 | K032620 | GE Voluson 730 Pro/Expert BT03 Ultrasound System | General Electric Co. | 2003 | — |
| −1 | K041688 | GE Voluson 730 Pro/Expert Untrasound BT04 | General Electric Co. | 2004 | 1 |
| 0 (this device) | K053435 | GE Voluson I | General Electric Co. | 2005 | — |
| +1 | K103649 | Voluson S6, Voluson S8 | GE Healthcare | 2011 | — |
| +1 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| +2 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| +3 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| +2 | K122387 | Voluson P6, Voluson P8 | GE Healthcare | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 8 | 0 |
| 2013 | 7 | 0 |
| 2014 | 17 | 0 |
| 2015 | 15 | 0 |
| 2016 | 22 | 0 |
| 2017 | 32 | 0 |
| 2018 | 39 | 0 |
| 2019 | 32 | 0 |
| 2020 | 39 | 0 |
| 2021 | 32 | 0 |
| 2022 | 40 | 0 |
| 2023 | 29 | 0 |
| 2024 | 36 | 0 |
| 2025 | 36 | 0 |
| 2026 | 19 | 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? (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 |
|---|---|---|---|
| * | K003525 | Voluson 730 Diagnostic Ultrasound SystemSummary page 1…1 CFR 892.1550, 90-IYN Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: Voluson 730 Pro/Expert Diagnostic Ultrasound - K003525, K032620, K041 688 A device currently in commercial distribution. 4. Device esrpto: The Voluson i is a… | 2000 |
| * | K032620 | GE Voluson 730 Pro/Expert BT03 Ultrasound SystemSummary page 1….1550, 90-IYN Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: Voluson 730 Pro/Expert Diagnostic Ultrasound - K003525, K032620, K041 688 A device currently in commercial distribution. 4. Device esrpto: The Voluson i is a compact,… | 2003 |
| * | K041688 | GE Voluson 730 Pro/Expert Untrasound BT04Summary page 1…-IYN Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: Voluson 730 Pro/Expert Diagnostic Ultrasound - K003525, K032620, K041 688 A device currently in commercial distribution. 4. Device esrpto: The Voluson i is a compact, general pu… | 2004 |
| * | — | GE LOGIQe Named without a submission number |
What descends from it? (407)
See all 4076 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103649 | Voluson S6, Voluson S8 | 2011 | 296 |
| K120741 | Voluson S6, Voluson S8 | 2012 | 295 |
| K082326 | Zonare Ultra Ultrasound System | 2008 | 133 |
| K131937 | Voluson I/E | 2013 | 35 |
| K132690 | UP600 Diagnostic Doppler Ultrasound System | 2014 | 3 |
| K121983 | Diagnostic Doppler Ultrasound System Curved Linear Array 2-5 MHZ Transducer Linear Array… | 2012 | 0 |
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 5 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K103649 (GE Healthcare, 2011) has gone furthest, with 296 descendants of its own.
- 9 other devices also cite its predicate K003525.
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:
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:
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K053435 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053435: GE Voluson I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053435
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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