510(k) · Cleared

Cleared

MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150

K052805510(k) TraditionalCleared Oct 17, 200513-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

Esaote, S.p.A. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Oct 17, 2005 as substantially equivalent to K040596 (Esaote, S.p.A., 2004) and 3 other predicates after a 13-day review. Its family tree reaches back 7 generations to 1995. 60 later devices descend from it.

Decided: Oct 17, 2005
Review: 13 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 4

Its longest line of descent runs back 7 generations to K944485 (1995). 22 ancestors in all, the oldest K934139 (1995). 60 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 7 generations backK944485 4000 AU Ultrasound Imaging SystemBiosound, Inc. · 1995
6 generations backK980468 AU5 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998
5 generations backK990360 AU6Biosound Esaote, Inc. · 1999
4 generations backK014168 AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D…Biosound Esaote, Inc. · 2002
3 generations backK040596 Ultrasound Imaging System, Model 7300Esaote, S.p.A. · 2004 · Recalled
2 generations backK050326 7350 Ultrasound Imaging System, Model 7350Esaote, S.p.A. · 2005 · Recalled
1 generation backK051308 Mylab 70 Ultrasound Imaging SystemEsaote, S.p.A. · 2005
This deviceK052805 MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150Esaote, S.p.A. · 2005
Descendant · cites it directly · 57 of its ownK081794 Model 7340 Ultrasound SystemEsaote, S.p.A. · 2008
Descendant · cites it directly · 51 of its ownK091009 MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY…Esaote, S.p.A. · 2009
Descendant · cites it directly · 35 of its ownK103152 6250 Ultrasound SytemsEsaote, S.p.A. · 2011
Descendant · 2 generations on · 34 of its ownK133905 6200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014
Descendant · cites it directly · 27 of its ownK070903 MYLAB40Esaote Europe B.V. · 2007

Showing 5 of 60 descendants. See all descendants

Descendants cleared per year

2007high 6 (2019) · low 0 (2015)2026

Most influential descendants

Showing 5 of 60 · See all

K081794Model 7340 Ultrasound SystemEsaote, S.p.A. · 2008 · cites it directly57descendants
K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A. · 2009 · cites it directly51descendants
K1031526250 Ultrasound SytemsEsaote, S.p.A. · 2011 · cites it directly35descendants
K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014 · 2 generations on34descendants
K070903MYLAB40Esaote Europe B.V. · 2007 · cites it directly27descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K944485	4000 AU Ultrasound Imaging System	Biosound, Inc.	1995	—
−6	K980468	AU5 Ultrasound Imaging System	Biosound Esaote, Inc.	1998	—
−5	K990360	AU6	Biosound Esaote, Inc.	1999	—
−4	K014168	AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging…	Biosound Esaote, Inc.	2002	—
−3	K040596	Ultrasound Imaging System, Model 7300	Esaote, S.p.A.	2004	4
−2	K050326	7350 Ultrasound Imaging System, Model 7350	Esaote, S.p.A.	2005	1
−1	K051308	Mylab 70 Ultrasound Imaging System	Esaote, S.p.A.	2005	—
0 (this device)	K052805	MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150	Esaote, S.p.A.	2005	—
+1	K081794	Model 7340 Ultrasound System	Esaote, S.p.A.	2008	—
+1	K091009	MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY…	Esaote, S.p.A.	2009	—
+1	K103152	6250 Ultrasound Sytems	Esaote, S.p.A.	2011	—
+2	K133905	6200 / 6250 Ultrasound System	Esaote, S.p.A.	2014	—
+1	K070903	MYLAB40	Esaote Europe B.V.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	2	0
1998	1	0
1999	1	0
2000	4	0
2002	3	0
2003	1	0
2004	2	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2008	1	0
2009	2	0
2010	1	0
2011	4	0
2012	3	0
2013	2	0
2014	5	0
2016	5	0
2017	4	0
2018	4	0
2019	6	0
2020	4	0
2021	2	0
2022	2	0
2023	2	0
2024	3	0
2025	5	0
2026	3	0

FIG. 1 — Lineage of K052805, 1995–2026Source: 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? (4)

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
*	K040596	Ultrasound Imaging System, Model 7300 Summary page 1 …ulsed echo imaging system 892.1560 Classification Number: 90IYN; 9O0YY) 807.92(a)(3) Predicate Device(s) K040596 7300 (MyLab3O) Esaote, Sp.A. K050326 7350 (MyLab5O)…	Esaote, S.p.A.	2004	4
*	K050326	7350 Ultrasound Imaging System, Model 7350 Summary page 1 …807.92(a)(3) Predicate Device(s) K040596 7300 (MyLab3O) Esaote, Sp.A. K050326 7350 (MyLab5O) Esaote, S.p.A. K051308 6150 (MyLab7O)…	Esaote, S.p.A.	2005	1
*	K051308	Mylab 70 Ultrasound Imaging System Summary page 1 …040596 7300 (MyLab3O) Esaote, Sp.A. K050326 7350 (MyLab5O) Esaote, S.p.A. K051308 6150 (MyLab7O) Esaote, S.p.A. K051837 61 00 (My Lab9O)…	Esaote, S.p.A.	2005	—
*	K051837	Mylab 90 Ultrasound Imaging System, Model 6100 Summary page 1 …50326 7350 (MyLab5O) Esaote, S.p.A. K051308 6150 (MyLab7O) Esaote, S.p.A. K051837 61 00 (My Lab9O) Esaote, Sp.A.…	Esaote, S.p.A.	2005	—

Also cleared against K040596: 5 other devices →

What descends from it? (60)

See all 60

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

Number	Device	Applicant	Decided	Descendants
K081794	Model 7340 Ultrasound System	Esaote, S.p.A.	2008	57
K091009	MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…	Esaote, S.p.A.	2009	51
K103152	6250 Ultrasound Sytems	Esaote, S.p.A.	2011	35
K070903	MYLAB40	Esaote Europe B.V.	2007	27
K111302	Mylabseven, Mylabalpha	Esaote, S.p.A.	2011	24
K142008	Mylabseven, Mylabalpha	Esaote, S.p.A.	2014	19
K071996	MYLAB30, Model 7300	Esaote, S.p.A.	2007	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 10 years and passes through 3 companies; a new generation was cleared every 11 months on median.
4 of the 22 ancestors have a recall of any class.
Of its descendants, K081794 (Esaote, S.p.A., 2008) has gone furthest, with 57 descendants of its own.
5 other devices also cite its predicate K040596.

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?

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/K052805 · printed Nov 4, 2026

Cite this page

510(k) Report. “K052805: MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052805

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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