510(k) · Cleared

Cleared

Pilot Model 9200 Blood Pressure Measurement System

K922668510(k) TraditionalCleared Jan 29, 19971,700-day reviewClass II21 CFR 870.1025

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

Colin Medical Instruments Corp. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Jan 29, 1997 after a 1,700-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 48 later devices descend from it.

Decided: Jan 29, 1997
Review: 1,700 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 0

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

This deviceK922668 Pilot Model 9200 Blood Pressure Measurement SystemColin Medical Instruments Corp. · 1997
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 48 descendants. See all descendants

Descendants cleared per year

1997high 6 (2026) · low 0 (1998)2026

Most influential descendants

Showing 5 of 48 · 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)	K922668	Pilot Model 9200 Blood Pressure Measurement System	Colin Medical Instruments Corp.	1997	—
+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
1997	1	0
2002	1	0
2005	1	0
2007	1	0
2008	3	0
2010	4	0
2011	3	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 K922668, 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 MHX? 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 MHX device

#1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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? (48)

See all 48

2 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
K964978	Vital Statistics System (O-Cath Accessory)	Quinton, Inc.	1997	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 MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MHX

8in 2025

2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007high 248 (2014) · low 57 (2009)2026

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

Recalls per year · MHX

21so far in 2026, the most since 2007

2007high 21 (2026) · low 0 (2020)2026

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

Adverse event reports per year · MHX

3,761in 2025

2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, 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	15	96	3	131
2008	16	58	2	232
2009	13	57	7	382
2010	20	90	13	955
2011	12	81	16	949
2012	16	88	11	676
2013	21	120	14	1,997
2014	13	248	6	1,609
2015	14	203	5	1,284
2016	13	149	7	1,105
2017	14	134	6	1,115
2018	11	203	12	2,157
2019	7	243	6	1,462
2020	11	196	0	1,714
2021	5	195	0	2,423
2022	15	189	6	1,470
2023	8	229	3	2,254
2024	5	181	3	2,814
2025	8	192	15	3,761
2026	14	205	21	—

https://510kreport.com/device/K922668 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922668: Pilot Model 9200 Blood Pressure Measurement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922668

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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