510(k) · Cleared
ClearedUltrasound System Model UF-3500
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 Feb 11, 1997 as substantially equivalent to K922208 (Fukuda Denshi USA, Inc., 1993) after a 434-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.
- Decided
- Feb 11, 1997
- Review
- 434 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922208 (1993). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK922208 Fukuda Denshi Model UF-4500Fukuda Denshi USA, Inc. · 1993
- This deviceK955543 Ultrasound System Model UF-3500Fukuda Denshi USA, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK990401 Fukuda Denshi FF Sonic UF-5800 General Purpose Ultrasound Scanning…Fukuda Denshi USA, Inc. · 1999
- Descendant · 2 generations on · 2 of its ownK033209 Fukuda Denshi Model FF Sonic UF-750XTFukuda Denshi USA, Inc. · 2003
- Descendant · 3 generations on · 0 of its ownK082656 Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging UnitFukuda Denshi USA, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK050363 Fukuda Denshi Model UF-850XTDFukuda Denshi USA, Inc. · 2005
Most influential descendants
Showing 4 of 4 · See all- K990401Fukuda Denshi FF Sonic UF-5800 General Purpose Ultrasound Scanning System with DopplerFukuda Denshi USA, Inc. · 1999 · cites it directly3descendants
- K033209Fukuda Denshi Model FF Sonic UF-750XTFukuda Denshi USA, Inc. · 2003 · 2 generations on2descendants
- K082656Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging UnitFukuda Denshi USA, Inc. · 2008 · 3 generations on0descendants
- K050363Fukuda Denshi Model UF-850XTDFukuda Denshi USA, Inc. · 2005 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922208 | Fukuda Denshi Model UF-4500 | Fukuda Denshi USA, Inc. | 1993 | — |
| 0 (this device) | K955543 | Ultrasound System Model UF-3500 | Fukuda Denshi USA, Inc. | 1997 | — |
| +1 | K990401 | Fukuda Denshi FF Sonic UF-5800 General Purpose Ultrasound Scanning System with… | Fukuda Denshi USA, Inc. | 1999 | — |
| +2 | K033209 | Fukuda Denshi Model FF Sonic UF-750XT | Fukuda Denshi USA, Inc. | 2003 | — |
| +3 | K082656 | Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging Unit | Fukuda Denshi USA, Inc. | 2008 | — |
| +3 | K050363 | Fukuda Denshi Model UF-850XTD | Fukuda Denshi USA, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 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? (1)
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 |
|---|---|---|---|
| * | K922208 | Fukuda Denshi Model UF-4500Summary page 1…anner Classification Name: ‘ System, Imaging, Pulsed Echo, Ultrasonic Legally Marketed Device: FUKUDA DENSHI FF sonic model UF-4500 General Purpose Ultrasound Scanner (K922208) UF-3500 510(k) Additional information K955543 January 16, 1997 SUMMAR~1-jan16.doc Page 1 of 5 Description: The… | 1993 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990401 | Fukuda Denshi FF Sonic UF-5800 General Purpose Ultrasound Scanning System with Doppler | 1999 | 3 |
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?
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?
This device is intended to be used for applications in fetal, abdominal, intra-operative, pediatric, small organ, trans-rectal, and peripheral vessel scanning. Ultrasonic probes are available to obtain images either transrectally or intraoperatively. It is intended to by used by or on the order of a physician or similarly qualified health care professional. The UF-3500 is intended to be used in a doctors office and all hospital environments; ER ICU, CCU…
Read the full statement (113 words)
This device is intended to be used for applications in fetal, abdominal, intra-operative, pediatric, small organ, trans-rectal, and peripheral vessel scanning. Ultrasonic probes are available to obtain images either transrectally or intraoperatively. It is intended to by used by or on the order of a physician or similarly qualified health care professional. The UF-3500 is intended to be used in a doctors office and all hospital environments; ER ICU, CCU, OR, etc. This device is intended to be use on any patient; neonate, pediatric, or adult; where the placement and positioning of the transducer does not interfere with or complicate the treatment of the patient. This device is not intended for home use.
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/K955543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955543: Ultrasound System Model UF-3500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955543
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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