510(k) · Cleared

Cleared

Imex Medical Systems, Inc. Imexlab 9100

K973562510(k) TraditionalCleared Apr 15, 1998208-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

Imex Medical Systems, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Apr 15, 1998 after a 208-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 50 later devices descend from it.

Decided: Apr 15, 1998
Review: 208 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 0

50 later devices descend from it, 3 citing it directly.

This deviceK973562 Imex Medical Systems, Inc. Imexlab 9100Imex Medical Systems, Inc. · 1998
Descendant · cites it directly · 46 of its ownK013434 VP-2000/1000Colin Corp. · 2002
Descendant · 2 generations on · 27 of its ownK082357 Microlife Upper Arm Automatic Digital Blood Pressure Monitor…Microlife Intellectual Property GmbH · 2008
Descendant · 3 generations on · 15 of its ownK151869 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 2015
Descendant · 4 generations on · 12 of its ownK153077 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2016
Descendant · 2 generations on · 8 of its ownK080670 Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical · 2008

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

2001high 6 (2026) · low 0 (2003)2026

Most influential descendants

Showing 5 of 50 · See all

K013434VP-2000/1000Colin Corp. · 2002 · cites it directly46descendants
K082357Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office…Microlife Intellectual Property GmbH · 2008 · 2 generations on27descendants
K151869Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 2015 · 3 generations on15descendants
K153077Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2016 · 4 generations on12descendants
K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical · 2008 · 2 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K973562	Imex Medical Systems, Inc. Imexlab 9100	Imex Medical Systems, Inc.	1998	—
+1	K013434	VP-2000/1000	Colin Corp.	2002	—
+2	K082357	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp…	Microlife Intellectual Property GmbH	2008	—
+3	K151869	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	Microlife Intellectual Property GmbH, Switzerland	2015	—
+4	K153077	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	Microlife Intellectual Property GmbH	2016	—
+2	K080670	Modification to Sphygmocor Cardiovascular Management System	Atcor Medical	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2005	1	0
2006	1	0
2007	1	0
2008	3	0
2010	4	0
2011	4	0
2012	2	0
2014	2	0
2015	3	0
2016	2	0
2017	2	0
2018	3	0
2019	2	0
2020	2	0
2021	2	0
2023	5	0
2024	2	0
2025	1	0
2026	6	0

FIG. 1 — Lineage of K973562, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (50)

See all 50

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

Number	Device	Applicant	Decided	Descendants
K013434	VP-2000/1000	Colin Corp.	2002	46
K063600	Vista Avs	Summit Doppler Systems, Inc.	2006	1
K012369	Basic, Models Basic 1, Basic 2, and Basic 3	Atys Medical	2001	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, K013434 (Colin Corp., 2002) has gone furthest, with 46 descendants of its own.

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?

The IMEXLAB 9100 is a non-invasive diagnostic system designed to assist in the

detection of peripheral vascular diseases.

Instrument is used in a vascular laboratory, clinic or hospital.

It for use by or on order of a physician.

It is not indicated for use near non-intact skin or the eyes.

It is not intended for home use.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973562 · printed Nov 5, 2026

Cite this page

510(k) Report. “K973562: Imex Medical Systems, Inc. Imexlab 9100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973562

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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