510(k) · Cleared
ClearedElectrocardiographic Cablhs & Lead Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tronomed, Inc. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Oct 18, 1977 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Oct 18, 1977
- Review
- 50 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK771645 Electrocardiographic Cablhs & Lead WireTronomed, Inc. · 1977
- Descendant · cites it directly · 1 of its ownK132253 Removable Patient Leads Ecg CableBoston Scientific · 2013
- Descendant · 2 generations on · 0 of its ownK172591 Fixed Patient Leads ECG Cable (Model 3153)Boston Scientific Corporation · 2017
- Descendant · cites it directly · 0 of its ownK984263 Ewc: Ecg II Cable Leadwire SystemEwc · 1999
- Descendant · cites it directly · 0 of its ownK982817 Ewc: Ecg Cable and Leadwire SystemsEwc · 1998
- Descendant · cites it directly · 0 of its ownK954900 3M Red Dot Ecg Lead Wires aMinnesota Mining and Mfg. Co. · 1996
Most influential descendants
Showing 5 of 5 · See all- K132253Removable Patient Leads Ecg CableBoston Scientific · 2013 · cites it directly1descendant
- K172591Fixed Patient Leads ECG Cable (Model 3153)Boston Scientific Corporation · 2017 · 2 generations on0descendants
- K984263Ewc: Ecg II Cable Leadwire SystemEwc · 1999 · cites it directly0descendants
- K982817Ewc: Ecg Cable and Leadwire SystemsEwc · 1998 · cites it directly0descendants
- K9549003M Red Dot Ecg Lead Wires aMinnesota Mining and Mfg. Co. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K771645 | Electrocardiographic Cablhs & Lead Wire | Tronomed, Inc. | 1977 | — |
| +1 | K132253 | Removable Patient Leads Ecg Cable | Boston Scientific | 2013 | — |
| +2 | K172591 | Fixed Patient Leads ECG Cable (Model 3153) | Boston Scientific Corporation | 2017 | — |
| +1 | K984263 | Ewc: Ecg II Cable Leadwire System | Ewc | 1999 | — |
| +1 | K982817 | Ewc: Ecg Cable and Leadwire Systems | Ewc | 1998 | — |
| +1 | K954900 | 3M Red Dot Ecg Lead Wires a | Minnesota Mining and Mfg. Co. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K132253 (Boston Scientific, 2013) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K771645 · printed Nov 5, 2026
Cite this page
510(k) Report. “K771645: Electrocardiographic Cablhs & Lead Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K771645
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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