510(k) · Cleared
ClearedEwc: Ecg Cable and Leadwire Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ewc · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Sep 23, 1998 as substantially equivalent to K771645 (Tronomed, Inc., 1977) and 2 other predicates after a 43-day review. Its family tree reaches back 1 generation to 1977.
- Decided
- Sep 23, 1998
- Review
- 43 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.
- Root · 1 generation backK770884 Elhctrocardiographic Connecting WiresTronomed, Inc. · 1977
- This deviceK982817 Ewc: Ecg Cable and Leadwire SystemsEwc · 1998
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) | K982817 | Ewc: Ecg Cable and Leadwire Systems | Ewc | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K771645 | Electrocardiographic Cablhs & Lead WireSummary page 1…alence: The EWC: ECG Cable and Leadwire Systems is substantially equivalent to the Tronomed Patient Cable and Lead Wire Systems which were marketed under 510(k) numbers; K771645, K771027 and K770884. 4. Device Description: The EWC: ECG Cable and Leadwire Systems are reuseable electrode cables designed to… | 1977 |
| * | K771027 | Electrocardiographic Patient CablesSummary page 1…he EWC: ECG Cable and Leadwire Systems is substantially equivalent to the Tronomed Patient Cable and Lead Wire Systems which were marketed under 510(k) numbers; K771645, K771027 and K770884. 4. Device Description: The EWC: ECG Cable and Leadwire Systems are reuseable electrode cables designed to transmit… | 1977 |
| * | K770884 | Elhctrocardiographic Connecting WiresSummary page 1…Cable and Leadwire Systems is substantially equivalent to the Tronomed Patient Cable and Lead Wire Systems which were marketed under 510(k) numbers; K771645, K771027 and K770884. 4. Device Description: The EWC: ECG Cable and Leadwire Systems are reuseable electrode cables designed to transmit signals from… | 1977 |
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 devicesDSA 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DSA
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSA
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSA
67in 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 Cable and Leadwire Systems are reusable electrode cable systems used to transmit signals from patient electrodes (not supplied by EWC) to various electrocardiograph recorders/monitors (not supplied by EWC) for both diagnostic and monitoring purposes. The EWC: ECG Cable and Leadwire Systems are limited by the indications 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/K982817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982817: Ewc: Ecg Cable and Leadwire Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982817
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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