510(k) Report

510(k) · Cleared

Cleared

Fukuda Denshi Model UF-4500

K922208510(k) TraditionalCleared Aug 30, 1993475-day reviewClass II21 CFR 892.1560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fukuda Denshi USA, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Aug 30, 1993 after a 475-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.

Decided
Aug 30, 1993
Review
475 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

6 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared1997: 1 descendant cleared2003: 1 descendant cleared2008: 1 descendant cleared2005: 1 descendant cleared1990200020102020
  1. This deviceK922208 Fukuda Denshi Model UF-4500Fukuda Denshi USA, Inc. · 1993
  2. Descendant · cites it directly · 4 of its ownK955543 Ultrasound System Model UF-3500Fukuda Denshi USA, Inc. · 1997
  3. Descendant · cites it directly · 3 of its ownK990401 Fukuda Denshi FF Sonic UF-5800 General Purpose Ultrasound Scanning…Fukuda Denshi USA, Inc. · 1999
  4. Descendant · 2 generations on · 2 of its ownK033209 Fukuda Denshi Model FF Sonic UF-750XTFukuda Denshi USA, Inc. · 2003
  5. Descendant · 3 generations on · 0 of its ownK082656 Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging UnitFukuda Denshi USA, Inc. · 2008
  6. Descendant · 3 generations on · 0 of its ownK050363 Fukuda Denshi Model UF-850XTDFukuda Denshi USA, Inc. · 2005

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1997: 11999: 22003: 12005: 12008: 1
1997high 2 (1999) · low 0 (1998)2026

Most influential descendants

Showing 5 of 6 · See all
  • K955543Ultrasound System Model UF-3500Fukuda Denshi USA, Inc. · 1997 · cites it directly4descendants
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K922208Fukuda Denshi Model UF-4500Fukuda Denshi USA, Inc.1993—
+1K955543Ultrasound System Model UF-3500Fukuda Denshi USA, Inc.1997—
+1K990401Fukuda Denshi FF Sonic UF-5800 General Purpose Ultrasound Scanning System with…Fukuda Denshi USA, Inc.1999—
+2K033209Fukuda Denshi Model FF Sonic UF-750XTFukuda Denshi USA, Inc.2003—
+3K082656Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging UnitFukuda Denshi USA, Inc.2008—
+3K050363Fukuda Denshi Model UF-850XTDFukuda Denshi USA, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199920
200310
200510
200810
FIG. 1 — Lineage of K922208, 1993–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (6)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K955543Ultrasound System Model UF-3500Fukuda Denshi USA, Inc.19974
K990401Fukuda Denshi FF Sonic UF-5800 General Purpose Ultrasound Scanning System with DopplerFukuda Denshi USA, Inc.19993
K990198AMIB7Alliance Medical, Inc.19990

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?

  • Of its descendants, K955543 (Fukuda Denshi USA, Inc., 1997) has gone furthest, with 4 descendants of its own.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

More from Fukuda Denshi USA, Inc.

68 FDA decisions under this applicant name. See the company

  • K173226CardiMax ElectrocardiographFukuda Denshi USA, Inc. · 2018
  • K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015
  • K134046Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc. · 20152 recalls
  • K112521Fukuda Denshi Vasera Model VS-1500Fukuda Denshi USA, Inc. · 2011
  • K103134Fukuda DenshiFukuda Denshi USA, Inc. · 2011

Recent decisions in IYO

The IYO category page

  • K262093Accuro XVRivanna Medical, Inc. · 2026
  • K260605Lilium one (USM330)Lilium Otsuka Co., Ltd. · 2026
  • K260313MD-6000S Bladder ScannerMEDA Co., Ltd. · 2026
  • K253452Accuro 3SRivanna Medical, Inc. · 2026
  • K260190ArthurROPCA ApS · 2026

https://510kreport.com/device/K922208 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922208: Fukuda Denshi Model UF-4500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922208

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026