510(k) Report

510(k) · Cleared

Cleared

EUB-405

K924126510(k) TraditionalCleared Dec 10, 1992115-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

Hitachi Medical Systems America, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Dec 10, 1992 after a 115-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 89 devices in its family, counting itself, has a Class I recall. 88 later devices descend from it.

Decided
Dec 10, 1992
Review
115 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

88 later devices descend from it, 2 citing it directly. 1 of the 89 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1999: 1 descendant cleared1997: 1 descendant cleared2001: 2 descendants cleared2002: 2 descendants cleared2003: 3 descendants cleared2007: 3 descendants cleared2004: 3 descendants cleared2006: 1 descendant cleared2005: 1 descendant cleared2012: 5 descendants cleared2009: 4 descendants cleared2011: 1 descendant cleared2015: 3 descendants cleared2016: 6 descendants cleared2010: 1 descendant cleared2008: 1 descendant cleared2020: 6 descendants cleared, 1 with a Class I recall12019: 7 descendants cleared2018: 6 descendants cleared2025: 6 descendants cleared2013: 3 descendants cleared2023: 5 descendants cleared2014: 3 descendants cleared2017: 4 descendants cleared2026: 3 descendants cleared2024: 2 descendants cleared2021: 1 descendant cleared2022: 4 descendants cleared1990200020102020
  1. This deviceK924126 EUB-405Hitachi Medical Systems America, Inc. · 1992
  2. Descendant · cites it directly · 86 of its ownK961974 FG-36UX, Ultrasound Upper GI FiberscopePentax Precision Instrument Corp. · 1997 · Recalled
  3. Descendant · 2 generations on · 59 of its ownK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
  4. Descendant · 3 generations on · 44 of its ownK031347 Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003
  5. Descendant · 3 generations on · 43 of its ownK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
  6. Descendant · 4 generations on · 28 of its ownK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled

Showing 5 of 88 descendants. See all descendants

Descendants cleared per year

1997: 11999: 12001: 22002: 22003: 32004: 32005: 12006: 12007: 32008: 12009: 42010: 12011: 12012: 52013: 32014: 32015: 32016: 62017: 42018: 62019: 72020: 62021: 12022: 42023: 52024: 22025: 62026: 3
1997high 7 (2019) · low 0 (1998)2026

Class I recalls in this family

  • K193517 ViziShot 2 FLEX7 generations on · 2020

Most influential descendants

Showing 5 of 88 · See all
  • K961974FG-36UX, Ultrasound Upper GI FiberscopePentax Precision Instrument Corp. · 1997 · cites it directly86descendants
  • K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · 2 generations on59descendants
  • K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003 · 3 generations on44descendants
  • K042140Olympus BF Type UC160-OL8Olympus Corporation · 2004 · 3 generations on43descendants
  • K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · 4 generations on28descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924126EUB-405Hitachi Medical Systems America, Inc.1992—
+1K961974FG-36UX, Ultrasound Upper GI FiberscopePentax Precision Instrument Corp.19972
+2K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd.20012
+3K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd.2003—
+3K042140Olympus BF Type UC160-OL8Olympus Corporation20041
+4K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation20055

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200120
200220
200330
200430
200510
200610
200730
200810
200940
201010
201110
201250
201330
201430
201530
201660
201740
201860
201970
202061
202110
202240
202350
202420
202560
202630
FIG. 1 — Lineage of K924126, 1992–2026Source: 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.

1 device in this family has a Class I recall. 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (88)

See all 88

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

NumberDeviceApplicantDecidedDescendants
K961974FG-36UX, Ultrasound Upper GI FiberscopePentax Precision Instrument Corp.199786
K990198AMIB7Alliance Medical, Inc.19990

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K961974 (Pentax Precision Instrument Corp., 1997) has gone furthest, with 86 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—

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https://510kreport.com/device/K924126 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924126: EUB-405.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924126

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