510(k) · Cleared

Cleared

Vision VXC Central Station, Model 4300

K061675510(k) SpecialCleared Aug 2, 200649-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

Invivo Corporation · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Aug 2, 2006 as substantially equivalent to K982104 (Medical Data Electronics, 1998) and 1 other predicate after a 49-day review. Its family tree reaches back 3 generations to 1993.

Decided: Aug 2, 2006
Review: 49 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K925411 (1993). 7 ancestors in all, the oldest K913193 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK925411 Model 2041-PC/ST Cardiac Telemetry MonitorAccucore, Inc. · 1993
2 generations backK972121 Acuity Central StationProtocol Systems, Inc. · 1997
1 generation backK022453 Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002 · Recalled
This deviceK061675 Vision VXC Central Station, Model 4300Invivo Corporation · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K925411	Model 2041-PC/ST Cardiac Telemetry Monitor	Accucore, Inc.	1993	—
−2	K972121	Acuity Central Station	Protocol Systems, Inc.	1997	—
−1	K022453	Modification to Acuity Central Monitoring System	Welch Allyn Protocol, Inc.	2002	1
0 (this device)	K061675	Vision VXC Central Station, Model 4300	Invivo Corporation	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1994	1	0
1998	1	0
2000	1	0

FIG. 1 — Lineage of K061675, 1993–2006Source: 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 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

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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
*	K982104	Escort-Link Central Station Monitor Model 20500 Summary page 2 …dicate devices: Predicate Device Manufacturer 510(k) No. Date Cleared Escort-Link Central Station Medical Data Electronics K982104 11/25/1998 Monitor Model 20500 Acuity Central Monitoring Welch Allyn Protocol, K022453 08/21/2002…	Medical Data Electronics	1998	—
*	K022453	Modification to Acuity Central Monitoring System Summary page 2 …cort-Link Central Station Medical Data Electronics K982104 11/25/1998 Monitor Model 20500 Acuity Central Monitoring Welch Allyn Protocol, K022453 08/21/2002 System Incorporated INTENDED USE The Vision VxC Series 4300 Central Station Monitor…	Welch Allyn Protocol, Inc.	2002	1
†	K012336	Modification to:Escort Vision Central Station Telemetry System, Model 20500	Medical Data Electronics	2001	—

Also cleared against K982104: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 13 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
1 of the 7 ancestors has a recall of any class.
1 other device also cites its predicate K982104.

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	—

What is it indicated for?

The Vision V x C series 4300 central station monitoring system is intended to be used to provide, using a wireless LAN for communication, centralized surveillance and documentation of patient vital sign data and arrhythnmia/ST monitoring for a variable number of Escort Bedside Monitors and a: variable number of UHF telemetry transmitters in the hospital environment. It is intended for use by healthcare practitioners trained in the use of the equipment only.

The ST algorithm has been tested for accuracy of the ST segment measurement data.

The significance of the ST segment changes must be determined by a physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061675 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061675: Vision VXC Central Station, Model 4300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061675

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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