510(k) · Cleared

Cleared

Ewc: Ecg II Cable Leadwire System

K984263510(k) AbbreviatedCleared Feb 2, 199964-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

Ewc · DSA Cable, Transducer And Electrode, Patient, (Including Connector)

Cleared on Feb 2, 1999 as substantially equivalent to K771645 (Tronomed, Inc., 1977) and 2 other predicates after a 64-day review. Its family tree reaches back 1 generation to 1977.

Decided: Feb 2, 1999
Review: 64 days
Class: Class II
Product code: DSA
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K770884 (1977). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK770884 Elhctrocardiographic Connecting WiresTronomed, Inc. · 1977
This deviceK984263 Ewc: Ecg II Cable Leadwire SystemEwc · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K770884	Elhctrocardiographic Connecting Wires	Tronomed, Inc.	1977	—
0 (this device)	K984263	Ewc: Ecg II Cable Leadwire System	Ewc	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1977	2	0

FIG. 1 — Lineage of K984263, 1977–1999Source: 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

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What was it cleared against? (3)

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 …ence: The EWC: ECG II Cable and Leadwire System is substantially equivalent to the Tronomed Patient Cable and Lead Wire Systems which were marketed under 510(k) numbers; K771645, K771027 and K770884. Corporate Centay - 70, V000 020 4. Device Description: The EWC: ECG Il Cable and Leadwire…	Tronomed, Inc.	1977	—
*	K771027	Electrocardiographic Patient Cables Summary page 1 …EWC: ECG II Cable and Leadwire System is substantially equivalent to the Tronomed Patient Cable and Lead Wire Systems which were marketed under 510(k) numbers; K771645, K771027 and K770884. Corporate Centay - 70, V000 020 4. Device Description: The EWC: ECG Il Cable and Leadwire System i…	Tronomed, Inc.	1977	—
*	K770884	Elhctrocardiographic Connecting Wires Summary page 1 …Cable and Leadwire System is substantially equivalent to the Tronomed Patient Cable and Lead Wire Systems which were marketed under 510(k) numbers; K771645, K771027 and K770884. Corporate Centay - 70, V000 020 4. Device Description: The EWC: ECG Il Cable and Leadwire System is a reusable…	Tronomed, Inc.	1977	—

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 3 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 EWC: ECG II Cable and Leadwire Systems are reusable electrode cable systems used to transmit signals from patient electrodes (not supplied by EWC) to various electrocardiographic recorders and/or monitors (not supplied by EWC) for both diagnostic and monitoring purposes. The EWC: ECG II Cable and Leadwire System is limited by the indication for use of the connected monitoring or diagnostic equipment. Such equipment is commonly located in hospitals, doctor's offices, emergency vehicles, as well as in home use.

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/K984263 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984263: Ewc: Ecg II Cable Leadwire System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984263

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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