510(k) · Cleared

Cleared

SA6000II Diagnostic Ultrasound System

K012887510(k) TraditionalCleared Sep 12, 200115-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 America, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Sep 12, 2001 as substantially equivalent to K992761 (Medison America, Inc., 1999) and 1 other predicate after a 15-day review. Its family tree reaches back 4 generations to 1993. 32 later devices descend from it.

Decided: Sep 12, 2001
Review: 15 days
Class: Class II
Product code: IYO
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K924432 (1993). 12 ancestors in all. 32 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
3 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
2 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
1 generation backK992761 Sonoace 5500 Diagnostic Ultrasound SystemMedison America, Inc. · 1999
This deviceK012887 SA6000II Diagnostic Ultrasound SystemMedison America, Inc. · 2001
Descendant · cites it directly · 30 of its ownK043588 Mylab 15 / Mylab 20, Model 2700Pie Medical · 2005
Descendant · 2 generations on · 29 of its ownK053154 MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical · 2005
Descendant · 2 generations on · 28 of its ownK061755 MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V. · 2006
Descendant · 2 generations on · 27 of its ownK070903 MYLAB40Esaote Europe B.V. · 2007
Descendant · 3 generations on · 26 of its ownK083882 MylabfiveEsaote Europe B.V. · 2009

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2005high 4 (2016) · low 0 (2008)2026

Most influential descendants

Showing 5 of 32 · See all

K043588Mylab 15 / Mylab 20, Model 2700Pie Medical · 2005 · cites it directly30descendants
K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical · 2005 · 2 generations on29descendants
K061755MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V. · 2006 · 2 generations on28descendants
K070903MYLAB40Esaote Europe B.V. · 2007 · 2 generations on27descendants
K083882MylabfiveEsaote Europe B.V. · 2009 · 3 generations on26descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K924432	Medison 1500	Medison Co., Ltd.	1993	—
−3	K981510	Sonoace 6000/ Ultramark 400	Medison America, Inc.	1998	—
−2	K990970	Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called…	Medison America, Inc.	1999	—
−1	K992761	Sonoace 5500 Diagnostic Ultrasound System	Medison America, Inc.	1999	—
0 (this device)	K012887	SA6000II Diagnostic Ultrasound System	Medison America, Inc.	2001	—
+1	K043588	Mylab 15 / Mylab 20, Model 2700	Pie Medical	2005	—
+2	K053154	MYLAB15/20 3D/4D Ultrasound Imaging System	Pie Medical	2005	—
+2	K061755	MYLAB15/20 New Indications Ultrasound System	Esaote Europe B.V.	2006	—
+2	K070903	MYLAB40	Esaote Europe B.V.	2007	—
+3	K083882	Mylabfive	Esaote Europe B.V.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1997	2	0
1998	2	0
1999	2	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	2	0
2007	1	0
2009	1	0
2010	1	0
2011	1	0
2013	2	0
2014	3	0
2016	4	0
2017	3	0
2018	2	0
2019	4	0
2021	1	0
2023	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K012887, 1993–2026Source: 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 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

Get a 510(k) Report

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
*	K992761	Sonoace 5500 Diagnostic Ultrasound System Summary page 1 …redicate or legally marketed device: Medison America, Inc. believes that SA600011 Ultrasound System is substantially equivalent to the currently marketed SA5500 System (K992761) and SA9900 System (K002185) Device Description: The SA60001! scanner is a general purpose, mobile, software controlled, diagno…	Medison America, Inc.	1999	—
*	K002185	Sonoace SA 9900 Diagnostic Ultrasound System Summary page 1 …device: Medison America, Inc. believes that SA600011 Ultrasound System is substantially equivalent to the currently marketed SA5500 System (K992761) and SA9900 System (K002185) Device Description: The SA60001! scanner is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its…	Medison America, Inc.	2000	1

What descends from it? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K043588	Mylab 15 / Mylab 20, Model 2700	Pie Medical	2005	30
K053530	Sonoace X4 Diagnostic Ultrasound System	Medison Co., Ltd.	2006	0

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 8 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
1 of the 12 ancestors has a recall of any class.
Of its descendants, K043588 (Pie Medical, 2005) has gone furthest, with 30 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	—

What is it indicated for?

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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/K012887 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012887: SA6000II Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012887

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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