510(k) · Cleared
ClearedUF-760AG
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 Apr 8, 2011 as substantially equivalent to K081919 (Fukuda Denshi Co., Ltd., 2008) and 3 other predicates after a 7-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Apr 8, 2011
- Review
- 7 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K003525 (2000). 8 ancestors in all, the oldest K002239 (2000). 1 later device descends from it, 1 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 deviceK110920 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 1 of 1 · See all- K131973Unexef-38G Ultrasound SystemToyota Tsusho Corporation · 2014 · cites it directly0descendants
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) | 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 |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K081919 | UF-870 AG Diagnostic Ultrasound SystemSummary page 1…892.1560 90-LYO Diagnostic Ultrasonic Transducer 21 CFR 892.1570 90-ITX 3. Equivalent Legally-Marketed Devices: Fukuda Denshi UF-870AG (K081919) GE, Voluson 730 (K003525, K032620 and K041688) The technological characteristics of the predicate device are the same as t… | 2008 |
| * | K003525 | Voluson 730 Diagnostic Ultrasound SystemSummary page 1…Diagnostic Ultrasonic Transducer 21 CFR 892.1570 90-ITX 3. Equivalent Legally-Marketed Devices: Fukuda Denshi UF-870AG (K081919) GE, Voluson 730 (K003525, K032620 and K041688) The technological characteristics of the predicate device are the same as those of the new device. 4… | 2000 |
| * | K032620 | GE Voluson 730 Pro/Expert BT03 Ultrasound SystemSummary page 1…Diagnostic Ultrasonic Transducer 21 CFR 892.1570 90-ITX 3. Equivalent Legally-Marketed Devices: Fukuda Denshi UF-870AG (K081919) GE, Voluson 730 (K003525, K032620 and K041688) The technological characteristics of the predicate device are the same as those of the new device. 4. Descrip… | 2003 |
| * | K041688 | GE Voluson 730 Pro/Expert Untrasound BT04Summary page 1…ostic Ultrasonic Transducer 21 CFR 892.1570 90-ITX 3. Equivalent Legally-Marketed Devices: Fukuda Denshi UF-870AG (K081919) GE, Voluson 730 (K003525, K032620 and K041688) The technological characteristics of the predicate device are the same as those of the new device. 4. Description The UF-… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131973 | Unexef-38G Ultrasound System | 2014 | 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 11 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K131973 (Toyota Tsusho Corporation, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K081919.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The system is intended for use by a qualified physician for diagnostic ultrasound imaging or fluid flow analysis of the human body in Fetal/Obstetric, Gynecological, Abdominal (renal, Gyn/Pelvic), Small Organ (thyroid, breast, testes, etc.), Adult Cephalic, Trans-vaginal, Trans-cranial, Musculoskeletal (conventional &superficial), Card iac-AdultlPediatric/Fetal, Transesophageal (Cardiac), Peripheral vascular. The UF-760AG ultrasound instrument is…
Read the full statement (92 words)
The system is intended for use by a qualified physician for diagnostic ultrasound imaging or fluid flow analysis of the human body in Fetal/Obstetric, Gynecological, Abdominal (renal, Gyn/Pelvic), Small Organ (thyroid, breast, testes, etc.), Adult Cephalic, Trans-vaginal, Trans-cranial, Musculoskeletal (conventional &superficial), Card iac-AdultlPediatric/Fetal, Transesophageal (Cardiac), Peripheral vascular.
The UF-760AG ultrasound instrument is intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode, 3D14D, harmonic imaging), lime motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Power Doppler, Doppler Tissue Imaging, Color Flow Mapping (CFM) and Color lime Motion (CM)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110920: UF-760AG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110920
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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