510(k) · Cleared

Cleared

Model 2041-PC/ST Cardiac Telemetry Monitor

K925411510(k) TraditionalCleared Feb 25, 1993122-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

Accucore, Inc. · DSI Detector And Alarm, Arrhythmia

Cleared on Feb 25, 1993 after a 122-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 66 later devices descend from it.

Decided: Feb 25, 1993
Review: 122 days
Class: Class II
Product code: DSI
Recalls: None
Predicates: 0

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

This deviceK925411 Model 2041-PC/ST Cardiac Telemetry MonitorAccucore, Inc. · 1993
Descendant · cites it directly · 64 of its ownK972121 Acuity Central StationProtocol Systems, Inc. · 1997
Descendant · 2 generations on · 63 of its ownK022453 Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002 · Recalled
Descendant · 2 generations on · 38 of its ownK052160 Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc. · 2005 · Recalled
Descendant · 3 generations on · 20 of its ownK122036 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
Descendant · 4 generations on · 18 of its ownK133586 Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

1997high 8 (2015) · low 0 (1999)2026

Most influential descendants

Showing 5 of 66 · See all

K972121Acuity Central StationProtocol Systems, Inc. · 1997 · cites it directly64descendants
K022453Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002 · 2 generations on63descendants
K052160Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc. · 2005 · 2 generations on38descendants
K122036Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · 3 generations on20descendants
K133586Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013 · 4 generations on18descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K925411	Model 2041-PC/ST Cardiac Telemetry Monitor	Accucore, Inc.	1993	—
+1	K972121	Acuity Central Station	Protocol Systems, Inc.	1997	—
+2	K022453	Modification to Acuity Central Monitoring System	Welch Allyn Protocol, Inc.	2002	1
+2	K052160	Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)	Welch Allyn, Inc.	2005	2
+3	K122036	Visi Mobile Monitoring System	Sotera Wireless, Inc.	2012	2
+4	K133586	Visi Mobile Monitioring System	Sotera Wireless, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
2002	1	0
2003	1	0
2005	1	0
2006	1	0
2007	2	0
2010	1	0
2011	1	0
2012	4	0
2013	2	0
2014	3	0
2015	8	0
2016	3	0
2017	1	0
2018	6	0
2019	3	0
2020	2	0
2021	2	0
2022	5	0
2023	3	0
2024	2	0
2025	8	0
2026	4	0

FIG. 1 — Lineage of K925411, 1993–2026Source: 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 DSI? 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 DSI device

#1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
#2 Held for the reportin the report
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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? (66)

See all 66

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

Number	Device	Applicant	Decided	Descendants
K972121	Acuity Central Station	Protocol Systems, Inc.	1997	64
K980045	Centurion Central Station Arrhythmia Patient Monitoring System	Invivo Research, Inc.	1998	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, K972121 (Protocol Systems, Inc., 1997) has gone furthest, with 64 descendants of its own.

How does its category compare?

All DSI devices

DSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSI

1in 2025

2007high 9 (2015) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSI

243in 2019

2007high 243 (2019) · low 70 (2008)2026

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

Recalls per year · DSI

18in 2025

2007high 18 (2025) · low 0 (2013)2026

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

Adverse event reports per year · DSI

712in 2025

2007high 4,352 (2016) · low 64 (2007)2025

MAUDE reports naming product code DSI, 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	7	151	4	64
2008	5	70	8	156
2009	6	73	3	279
2010	6	111	5	823
2011	6	114	3	793
2012	3	113	1	766
2013	1	—	0	795
2014	4	200	0	1,000
2015	9	127	0	1,645
2016	6	224	0	4,352
2017	0	—	0	3,594
2018	2	—	1	3,648
2019	3	243	4	3,485
2020	2	—	2	3,084
2021	0	—	0	3,092
2022	0	—	1	1,638
2023	2	—	2	1,616
2024	1	—	0	1,320
2025	1	—	18	712
2026	1	—	1	—

https://510kreport.com/device/K925411 · printed Nov 6, 2026

Cite this page

510(k) Report. “K925411: Model 2041-PC/ST Cardiac Telemetry Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925411

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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