510(k) · Cleared

Cleared

MS-2000

K961144510(k) TraditionalCleared Mar 12, 1997356-day reviewClass II21 CFR 870.1130

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

Touritu Engineering Co., Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Mar 12, 1997 after a 356-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 20 later devices descend from it.

Decided: Mar 12, 1997
Review: 356 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 0

20 later devices descend from it, 2 citing it directly.

This deviceK961144 MS-2000Touritu Engineering Co., Inc. · 1997
Descendant · cites it directly · 18 of its ownK061961 Art Lab SoftwarePie Medical · 2006
Descendant · 2 generations on · 12 of its ownK153277 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016
Descendant · 3 generations on · 9 of its ownK163082 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · Recalled
Descendant · 4 generations on · 8 of its ownK173291 6440 Ultrasound SystemEsaote, S.p.A. · 2018
Descendant · 5 generations on · 4 of its ownK230179 6440 MyLabX90Esaote, S.p.A. · 2023 · Recalled

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2002high 4 (2019) · low 0 (2003)2026

Most influential descendants

Showing 5 of 20 · See all

K061961Art Lab SoftwarePie Medical · 2006 · cites it directly18descendants
K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016 · 2 generations on12descendants
K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · 3 generations on9descendants
K1732916440 Ultrasound SystemEsaote, S.p.A. · 2018 · 4 generations on8descendants
K2301796440 MyLabX90Esaote, S.p.A. · 2023 · 5 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K961144	MS-2000	Touritu Engineering Co., Inc.	1997	—
+1	K061961	Art Lab Software	Pie Medical	2006	—
+2	K153277	6200 Ultrasound System and 6250 Ultrasound System	Esaote, S.p.A.	2016	—
+3	K163082	6200 Ultrasound System and 6250 Ultrasound System	Esaote, S.p.A.	2017	2
+4	K173291	6440 Ultrasound System	Esaote, S.p.A.	2018	—
+5	K230179	6440 MyLabX90	Esaote, S.p.A.	2023	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2006	1	0
2016	3	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 K961144, 1997–2026Source: 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 DXN? 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 DXN device

#1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K061961	Art Lab Software	Pie Medical	2006	18
K011625	Vasocor Vascular Diagnostic Center (Model 300)	Vasocor, Inc.	2002	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?

Of its descendants, K061961 (Pie Medical, 2006) has gone furthest, with 18 descendants of its own.

How does its category compare?

All DXN devices

DXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXN

28in 2025

2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007high 235 (2018) · low 72 (2011)2026

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

Recalls per year · DXN

3in 2024

2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXN

239in 2025

2007high 617 (2018) · low 8 (2008)2025

MAUDE reports naming product code DXN, 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	27	118	0	21
2008	23	82	1	8
2009	46	73	3	17
2010	43	94	0	14
2011	34	72	1	10
2012	36	116	0	19
2013	34	150	1	72
2014	29	133	0	47
2015	30	97	0	62
2016	30	144	1	54
2017	33	184	0	90
2018	22	235	0	617
2019	33	156	1	96
2020	24	198	0	130
2021	23	190	0	162
2022	25	137	0	155
2023	35	182	0	162
2024	17	107	3	270
2025	28	142	0	239
2026	29	147	0	—

https://510kreport.com/device/K961144 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961144: MS-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961144

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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