510(k) · Cleared

Cleared

Modifications to Eub-525 Diagnostic Ultrasound Scanner; Eub-2000 Diagnostic Ultrasound Scanner; SP-711 Sonoprobe System

K012239510(k) TraditionalCleared Aug 10, 200124-day reviewClass II21 CFR 892.1550

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

Hitachi Medical Corp. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Aug 10, 2001 as substantially equivalent to K981434 (Hitachi Medical Corp. of America, 1998) and 1 other predicate after a 24-day review. Its family tree reaches back 2 generations to 1997.

Decided: Aug 10, 2001
Review: 24 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K954220 (1997). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK954220 EUB-8000Hitachi Medical Corp. of America · 1997
1 generation backK981434 Eup-OL334 LaparascopicprobeHitachi Medical Corp. of America · 1998
This deviceK012239 Modifications to Eub-525 Diagnostic Ultrasound Scanner; Eub-2000…Hitachi Medical Corp. · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K954220	EUB-8000	Hitachi Medical Corp. of America	1997	—
−1	K981434	Eup-OL334 Laparascopicprobe	Hitachi Medical Corp. of America	1998	—
0 (this device)	K012239	Modifications to Eub-525 Diagnostic Ultrasound Scanner; Eub-2000 Diagnostic…	Hitachi Medical Corp.	2001	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K012239, 1997–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K981434	Eup-OL334 Laparascopicprobe Summary page 1 …0 which allows the EUB-525/EUB-2000 to utilize the Fujinon probes. The Hitachi EUB-525 Diagnostic Ultrasound Scanner has previously been cleared by the FDA under 510(k) K981434. The Hitachi EUB-2000 was introduced as a modification of the EUB-525 under Appendix E of Information for Manufacturers Seeking M…	Hitachi Medical Corp. of America	1998	—
*	K011252	Eub-6000 Diagnostic Ultrasound Scanner SP-711 Sonoprobe System Summary page 1 …nd Systems and Transducers, dated September 30, 1997. The Fujinon SP711 Sonoprobe system was previously cleared for use with the Hitachi EUB-6000 by the FDA under 510(k) K011252. HITACHI EUB-S2VEUB-2000 / FUJINON SP-711 SECTION 4.7 Page 37 Description Of The Device The subject device con…	Hitachi Medical Corp.	2001	—

Also cleared against K981434: 2 other devices →

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 3.0 years on median.
None of the 3 ancestors has a recall.
2 other devices also cite its predicate K981434.

How does its category compare?

All IYN devices

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

FDA decisions per year · IYN

57in 2025

2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007high 610 (2025) · low 2 (2008)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 intended use of the subject device is for endoscopic observation of the gastrointestinal tract (esophagus, stomach, duodenum, large intestine) and biliary system (pancreato-biliary ducts).

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/K012239 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012239: Modifications to Eub-525 Diagnostic Ultrasound Scanner; Eub-2000 Diagnostic Ultrasound Scanner; SP-711 Sonoprobe System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012239

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026