510(k) · Cleared
ClearedFukuda Denshi Ultrasound Scanners Models UF-3500 and UF-4500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fukuda Denshi USA, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 20, 1998 as substantially equivalent to K961459 (Advanced Technology Laboratories, Inc., 1997) and 1 other predicate after a 33-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- May 20, 1998
- Review
- 33 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K933202 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933202 | Venus Diagnostic Ultrasound System | GE Medical Systems | 1994 | — |
| −1 | K970901 | GE Logiq 500 Diagnostic Ultrasound System | GE Medical Systems | 1997 | — |
| 0 (this device) | K981404 | Fukuda Denshi Ultrasound Scanners Models UF-3500 and UF-4500 | Fukuda Denshi USA, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K961459 | Level 10 HdiSummary page 1…ame: Ultrasonic Pulsed Echo Imaging System (§892.1560) Diagnostiq Ultrasonic Transducer (§892.1560) Legally Marketed Device: e ATL model Level 10 HD! Ultrasound System (K961459) ¢ GE Model LOGIQ 500 (k970901 Musculoskeletal 510(k) Submission March 31, 1998 510(k) Summary.doc Page 1 of 3 D… | 1997 |
| * | K970901 | GE Logiq 500 Diagnostic Ultrasound SystemSummary page 1…ging System (§892.1560) Diagnostiq Ultrasonic Transducer (§892.1560) Legally Marketed Device: e ATL model Level 10 HD! Ultrasound System (K961459) ¢ GE Model LOGIQ 500 (k970901 Musculoskeletal 510(k) Submission March 31, 1998 510(k) Summary.doc Page 1 of 3 Description: The Fukuda Denshi… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 3 ancestors has a recall.
- 15 other devices also cite its predicate K961459.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 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
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/K981404 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981404: Fukuda Denshi Ultrasound Scanners Models UF-3500 and UF-4500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981404
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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