510(k) · Cleared
ClearedSigma 110/330 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kontron Medical Systems Sas · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 8, 2000 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Aug 8, 2000
- Review
- 15 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK002239 Sigma 110/330 Diagnostic Ultrasound SystemKontron Medical Systems Sas · 2000
- Descendant · cites it directly · 3 of its ownK061437 Sigma 5000 Series, ImagicKontron Medical Systems Sas · 2006
- Descendant · cites it directly · 3 of its ownK053084 Sigma 5000 Series Imagic Ultrasound SystemKontron Medical Systems Sas · 2005
- Descendant · cites it directly · 3 of its ownK050099 Sigma 5000 Series Imagic Ultrasound SystemKontron Medical Systems Sas · 2005
- Descendant · 2 generations on · 2 of its ownK081919 UF-870 AG Diagnostic Ultrasound SystemFukuda Denshi Co., Ltd. · 2008
- Descendant · 3 generations on · 1 of its ownK110920 UF-760AGFukuda Denshi Co., Ltd. · 2011
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K061437Sigma 5000 Series, ImagicKontron Medical Systems Sas · 2006 · cites it directly3descendants
- K053084Sigma 5000 Series Imagic Ultrasound SystemKontron Medical Systems Sas · 2005 · cites it directly3descendants
- K050099Sigma 5000 Series Imagic Ultrasound SystemKontron Medical Systems Sas · 2005 · cites it directly3descendants
- K081919UF-870 AG Diagnostic Ultrasound SystemFukuda Denshi Co., Ltd. · 2008 · 2 generations on2descendants
- K110920UF-760AGFukuda Denshi Co., Ltd. · 2011 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002239 | Sigma 110/330 Diagnostic Ultrasound System | Kontron Medical Systems Sas | 2000 | — |
| +1 | K061437 | Sigma 5000 Series, Imagic | Kontron Medical Systems Sas | 2006 | — |
| +1 | K053084 | Sigma 5000 Series Imagic Ultrasound System | Kontron Medical Systems Sas | 2005 | — |
| +1 | K050099 | Sigma 5000 Series Imagic Ultrasound System | Kontron Medical Systems Sas | 2005 | — |
| +2 | K081919 | UF-870 AG Diagnostic Ultrasound System | Fukuda Denshi Co., Ltd. | 2008 | — |
| +3 | K110920 | UF-760AG | Fukuda Denshi Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K061437 (Kontron Medical Systems Sas, 2006) has gone furthest, with 3 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/K002239 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002239: Sigma 110/330 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/K002239
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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