510(k) · Cleared
ClearedFukuda Denshi Model UF-850XTD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fukuda Denshi USA, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Feb 17, 2005 as substantially equivalent to K033209 (Fukuda Denshi USA, Inc., 2003) after a 3-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Feb 17, 2005
- Review
- 3 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K922208 (1993). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK922208 Fukuda Denshi Model UF-4500Fukuda Denshi USA, Inc. · 1993
- 3 generations backK955543 Ultrasound System Model UF-3500Fukuda Denshi USA, Inc. · 1997
- 2 generations backK990401 Fukuda Denshi FF Sonic UF-5800 General Purpose Ultrasound Scanning…Fukuda Denshi USA, Inc. · 1999
- 1 generation backK033209 Fukuda Denshi Model FF Sonic UF-750XTFukuda Denshi USA, Inc. · 2003
- This deviceK050363 Fukuda Denshi Model UF-850XTDFukuda Denshi USA, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922208 | Fukuda Denshi Model UF-4500 | Fukuda Denshi USA, Inc. | 1993 | — |
| −3 | K955543 | Ultrasound System Model UF-3500 | Fukuda Denshi USA, Inc. | 1997 | — |
| −2 | K990401 | Fukuda Denshi FF Sonic UF-5800 General Purpose Ultrasound Scanning System with… | Fukuda Denshi USA, Inc. | 1999 | — |
| −1 | K033209 | Fukuda Denshi Model FF Sonic UF-750XT | Fukuda Denshi USA, Inc. | 2003 | — |
| 0 (this device) | K050363 | Fukuda Denshi Model UF-850XTD | Fukuda Denshi USA, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 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? (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 |
|---|---|---|---|
| * | K033209 | Fukuda Denshi Model FF Sonic UF-750XTSummary page 3…better than the current legally marketed predicate device, the Fukuda Denshi model UJF-750 XT. (5 10(k) No.. K033209 UF-850 XTI)Special 510(k) subrmision Page 3 of 3 2/10/05 510 (kc) Summay… | 2003 |
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 12 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K033209.
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) | — |
What is it indicated for?
The device is intended to be used for applications in fetal, abdominal, pediatric, small organ (defined as the thyroid, breast and testes), cardiac (adult and pediatric), transvaginal, peripheral vessel and musculo-skeletal (Conventional and Superficial). The UF-85OXTD incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The UF-85OXTD is a prescription device intended to be use by or on…
Read the full statement (116 words)
The device is intended to be used for applications in fetal, abdominal, pediatric, small organ (defined as the thyroid, breast and testes), cardiac (adult and pediatric), transvaginal, peripheral vessel and musculo-skeletal (Conventional and Superficial). The UF-85OXTD incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The UF-85OXTD is a prescription device intended to be use by or on the order of a physician or similarly qualified healthcare professional. The device is intended to be used 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 as stated in the FDA summary.
https://510kreport.com/device/K050363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050363: Fukuda Denshi Model UF-850XTD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050363
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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