510(k) · Cleared

Cleared

Medison 1500

K924432510(k) TraditionalCleared Nov 24, 1993449-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

Medison Co., Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Nov 24, 1993 after a 449-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 213 later devices descend from it.

Decided: Nov 24, 1993
Review: 449 days
Class: Class II
Product code: IYO
Recalls: None
Predicates: 0

213 later devices descend from it, 1 citing it directly.

This deviceK924432 Medison 1500Medison Co., Ltd. · 1993
Descendant · cites it directly · 212 of its ownK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
Descendant · 2 generations on · 209 of its ownK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
Descendant · 3 generations on · 207 of its ownK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
Descendant · 4 generations on · 204 of its ownK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
Descendant · 4 generations on · 184 of its ownK031552 Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · Recalled

Showing 5 of 213 descendants. See all descendants

Descendants cleared per year

1998high 17 (2018) · low 0 (2002)2026

Most influential descendants

Showing 5 of 213 · See all

K981510Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998 · cites it directly212descendants
K990970Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called Ultrasound…Medison America, Inc. · 1999 · 2 generations on209descendants
K002185Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · 3 generations on207descendants
K013627Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001 · 4 generations on204descendants
K031552Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · 4 generations on184descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K924432	Medison 1500	Medison Co., Ltd.	1993	—
+1	K981510	Sonoace 6000/ Ultramark 400	Medison America, Inc.	1998	—
+2	K990970	Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called…	Medison America, Inc.	1999	—
+3	K002185	Sonoace SA 9900 Diagnostic Ultrasound System	Medison America, Inc.	2000	1
+4	K013627	Sonoace SA-8000 Diagnostic Ultrasound System	Medison America, Inc.	2001	—
+4	K031552	Mycolor 202 Diagnostic Ultrasound System and Transducers	Medison America, Inc.	2003	5

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	2	0
2000	1	0
2001	2	0
2003	2	0
2004	2	0
2005	3	0
2006	6	0
2007	4	0
2008	5	0
2009	5	0
2010	7	0
2011	9	0
2012	5	0
2013	7	0
2014	9	0
2015	5	0
2016	11	0
2017	15	0
2018	17	0
2019	17	0
2020	11	0
2021	13	0
2022	14	0
2023	10	0
2024	9	0
2025	13	0
2026	8	0

FIG. 1 — Lineage of K924432, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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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? (213)

See all 213

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K981510	Sonoace 6000/ Ultramark 400	Medison America, Inc.	1998	212

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, K981510 (Medison America, Inc., 1998) has gone furthest, with 212 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

2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

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

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

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	—

https://510kreport.com/device/K924432 · printed Nov 4, 2026

Cite this page

510(k) Report. “K924432: Medison 1500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924432

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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