510(k) · Cleared
ClearedUF-870 AG Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fukuda Denshi Co., Ltd. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Sep 9, 2008 as substantially equivalent to K050099 (Kontron Medical Systems Sas, 2005) and 2 other predicates after a 64-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Sep 9, 2008
- Review
- 64 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002239 (2000). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002239 Sigma 110/330 Diagnostic Ultrasound SystemKontron Medical Systems Sas · 2000
- 1 generation backK050099 Sigma 5000 Series Imagic Ultrasound SystemKontron Medical Systems Sas · 2005
- This deviceK081919 UF-870 AG Diagnostic Ultrasound SystemFukuda Denshi Co., Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK110920 UF-760AGFukuda Denshi Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK131973 Unexef-38G Ultrasound SystemToyota Tsusho Corporation · 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 |
|---|---|---|---|---|---|
| −2 | K002239 | Sigma 110/330 Diagnostic Ultrasound System | Kontron Medical Systems Sas | 2000 | — |
| −1 | K050099 | Sigma 5000 Series Imagic Ultrasound System | Kontron Medical Systems Sas | 2005 | — |
| 0 (this device) | K081919 | UF-870 AG Diagnostic Ultrasound System | Fukuda Denshi Co., Ltd. | 2008 | — |
| +1 | K110920 | UF-760AG | Fukuda Denshi Co., Ltd. | 2011 | — |
| +1 | K131973 | Unexef-38G Ultrasound System | Toyota Tsusho Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K050099 | Sigma 5000 Series Imagic Ultrasound SystemSummary page 1…R 892.1560 90-IYO Diagnostic Ultrasonic Transducer 21 CFR 892.1570 90-ITX 3. Equivalent Legally-Marketed Devices: Kontron Medical Sigma 5000 Series Imagic, K050099, K053084, K06 1437 The technological characteristics of the predicate device are the same as those of the new device. 4. Desc… | 2005 |
| * | K053084 | Sigma 5000 Series Imagic Ultrasound SystemSummary page 1…0 90-IYO Diagnostic Ultrasonic Transducer 21 CFR 892.1570 90-ITX 3. Equivalent Legally-Marketed Devices: Kontron Medical Sigma 5000 Series Imagic, K050099, K053084, K06 1437 The technological characteristics of the predicate device are the same as those of the new device. 4. Description… | 2005 |
| * | K061437 | Sigma 5000 Series, ImagicSummary page 1…-IYO Diagnostic Ultrasonic Transducer 21 CFR 892.1570 90-ITX 3. Equivalent Legally-Marketed Devices: Kontron Medical Sigma 5000 Series Imagic, K050099, K053084, K06 1437 The technological characteristics of the predicate device are the same as those of the new device. 4. Description The UF-… | 2006 |
What descends from it? (2)
2 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K110920 (Fukuda Denshi Co., Ltd., 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081919: UF-870 AG Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081919
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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