510(k) · Cleared

Cleared

Mylab 15 / Mylab 20, Model 2700

K043588510(k) TraditionalCleared Jan 25, 200528-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

Pie Medical · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Jan 25, 2005 as substantially equivalent to K023512 (Pie Medical, 2003) and 1 other predicate after a 28-day review. Its family tree reaches back 5 generations to 1993. 30 later devices descend from it.

Decided: Jan 25, 2005
Review: 28 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 2

Its longest line of descent runs back 5 generations to K924432 (1993). 16 ancestors in all. 30 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 5 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
4 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
3 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
2 generations backK992761 Sonoace 5500 Diagnostic Ultrasound SystemMedison America, Inc. · 1999
1 generation backK012887 SA6000II Diagnostic Ultrasound SystemMedison America, Inc. · 2001
This deviceK043588 Mylab 15 / Mylab 20, Model 2700Pie Medical · 2005
Descendant · cites it directly · 29 of its ownK053154 MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical · 2005
Descendant · cites it directly · 28 of its ownK061755 MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V. · 2006
Descendant · cites it directly · 27 of its ownK070903 MYLAB40Esaote Europe B.V. · 2007
Descendant · 2 generations on · 26 of its ownK083882 MylabfiveEsaote Europe B.V. · 2009
Descendant · 3 generations on · 25 of its ownK101605 Mylabone Ultrasound SystemEsaote Europe B.V. · 2010

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2005high 4 (2016) · low 0 (2008)2026

Most influential descendants

Showing 5 of 30 · See all

K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical · 2005 · cites it directly29descendants
K061755MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V. · 2006 · cites it directly28descendants
K070903MYLAB40Esaote Europe B.V. · 2007 · cites it directly27descendants
K083882MylabfiveEsaote Europe B.V. · 2009 · 2 generations on26descendants
K101605Mylabone Ultrasound SystemEsaote Europe B.V. · 2010 · 3 generations on25descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K924432	Medison 1500	Medison Co., Ltd.	1993	—
−4	K981510	Sonoace 6000/ Ultramark 400	Medison America, Inc.	1998	—
−3	K990970	Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called…	Medison America, Inc.	1999	—
−2	K992761	Sonoace 5500 Diagnostic Ultrasound System	Medison America, Inc.	1999	—
−1	K012887	SA6000II Diagnostic Ultrasound System	Medison America, Inc.	2001	—
0 (this device)	K043588	Mylab 15 / Mylab 20, Model 2700	Pie Medical	2005	—
+1	K053154	MYLAB15/20 3D/4D Ultrasound Imaging System	Pie Medical	2005	—
+1	K061755	MYLAB15/20 New Indications Ultrasound System	Esaote Europe B.V.	2006	—
+1	K070903	MYLAB40	Esaote Europe B.V.	2007	—
+2	K083882	Mylabfive	Esaote Europe B.V.	2009	—
+3	K101605	Mylabone Ultrasound System	Esaote Europe B.V.	2010	—

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	3	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	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 K043588, 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 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

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
*	K023512	Picus Ultrasound Imaging Systems Summary page 1 …90IYN 807.92(a)(3) Predicate Device(s) Pie Medical Picus K023512 Medison 128BW K0 12887 Additional Substantial Equivalence Informati…	Pie Medical	2003	—
*	K012887	SA6000II Diagnostic Ultrasound System Summary page 1 …e Device(s) Pie Medical Picus K023512 Medison 128BW K0 12887 Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.…	Medison America, Inc.	2001	—

Also cleared against K023512: 1 other device →

What descends from it? (30)

See all 30

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

Number	Device	Applicant	Decided	Descendants
K053154	MYLAB15/20 3D/4D Ultrasound Imaging System	Pie Medical	2005	29
K061755	MYLAB15/20 New Indications Ultrasound System	Esaote Europe B.V.	2006	28
K070903	MYLAB40	Esaote Europe B.V.	2007	27

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 12 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
1 of the 16 ancestors has a recall of any class.
Of its descendants, K053154 (Pie Medical, 2005) has gone furthest, with 29 descendants of its own.
1 other device also cites its predicate K023512.

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?

Esaote's MyLabI 5/MyLab2O is a compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies including Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal (Conventional and Superficial).

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/K043588 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043588: Mylab 15 / Mylab 20, Model 2700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043588

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026