510(k) · Cleared

Cleared

3M Red Dot Ecg Lead Wires a

K954900510(k) TraditionalCleared Jul 15, 1996264-day reviewClass II21 CFR 870.2900

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

Minnesota Mining and Mfg. Co. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)

Cleared on Jul 15, 1996 as substantially equivalent to K771645 (Tronomed, Inc., 1977) and 1 other predicate after a 264-day review. Its family tree reaches back 1 generation to 1977.

Decided: Jul 15, 1996
Review: 264 days
Class: Class II
Product code: DSA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K771645 (1977). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK771645 Electrocardiographic Cablhs & Lead WireTronomed, Inc. · 1977
This deviceK954900 3M Red Dot Ecg Lead Wires aMinnesota Mining and Mfg. Co. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K771645	Electrocardiographic Cablhs & Lead Wire	Tronomed, Inc.	1977	—
0 (this device)	K954900	3M Red Dot Ecg Lead Wires a	Minnesota Mining and Mfg. Co.	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0

FIG. 1 — Lineage of K954900, 1977–1996Source: 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 DSA? 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 DSA device

#1 K252827 IBP cable Becton Dickinson (2606488); IBP…score 11.3 · 4 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? (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
*	K771645	Electrocardiographic Cablhs & Lead Wire Summary page 1 …21 C.F.R. 870.2360. This device was reviewed by the Cardiovascular Device Panel. 5. Predicate Devices to which 3M is claiming Substantial Equivalence: Tronomed 510(k) K771645 P/N D-3A1505-8-C Vital Connections 510(k) K880320 P/N RTR 5925 -30- 510(k) Submisssion 3M Red Dot ECG Lead Wire…	Tronomed, Inc.	1977	—
*	K880320	Electrode Cable Summary page 1 …e Cardiovascular Device Panel. 5. Predicate Devices to which 3M is claiming Substantial Equivalence: Tronomed 510(k) K771645 P/N D-3A1505-8-C Vital Connections 510(k) K880320 P/N RTR 5925 -30- 510(k) Submisssion 3M Red Dot ECG Lead Wires Description of the Devices: Components of the D…	Vital Connections, Inc.	1988	—

Also cleared against K771645: 3 other devices →

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?

None of the 2 ancestors has a recall.
3 other devices also cite its predicate K771645.

How does its category compare?

All DSA devices

DSA Cable, Transducer And Electrode, Patient, (Including Connector): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSA

4in 2025

2007high 6 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSA

105in 2025

2007high 240 (2023) · low 55 (2010)2026

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

Recalls per year · DSA

1in 2022

2007high 2 (2010) · low 0 (2007)2026

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

Adverse event reports per year · DSA

67in 2025

2007high 67 (2014) · low 1 (2010)2025

MAUDE reports naming product code DSA, 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	2	—	0	4
2008	6	59	0	11
2009	0	—	0	5
2010	4	55	2	1
2011	1	—	0	4
2012	1	—	0	8
2013	1	—	0	23
2014	1	—	0	67
2015	0	—	0	34
2016	2	—	0	28
2017	5	140	0	5
2018	3	84	0	16
2019	4	140	0	11
2020	6	177	0	31
2021	4	164	0	7
2022	2	—	1	49
2023	3	240	0	29
2024	3	102	0	40
2025	4	105	0	67
2026	1	—	0	—

What is it indicated for?

The ECG lead wire is intended only for the purpose of connecting an ECG monitoring electrode to either an ECG monitor trunk cable or directly into a monitor or transmitter and conducting the patients ECG signal.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K954900 · printed Nov 5, 2026

Cite this page

510(k) Report. “K954900: 3M Red Dot Ecg Lead Wires a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954900

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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