510(k) · Cleared
ClearedMulti-Link Cable and Lead Wire Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marquette Medical Systems, Inc. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Mar 16, 1998 as substantially equivalent to K933649 (Conmedcorp, 1994) after a 27-day review. Its family tree reaches back 1 generation to 1994. 10 later devices descend from it.
- Decided
- Mar 16, 1998
- Review
- 27 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933649 (1994). 10 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK933649 Conmed Ecg Patient Cables and LeadwiresConmedcorp · 1994
- This deviceK980582 Multi-Link Cable and Lead Wire SystemsMarquette Medical Systems, Inc. · 1998
- Descendant · cites it directly · 7 of its ownK082851 Multlink Cable and Leadwire SystemGe Medical Systems Information Technologies · 2008
- Descendant · cites it directly · 6 of its ownK101660 Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8Kepler Medtec · 2010
- Descendant · cites it directly · 3 of its ownK162432 Multi-Link X2 ECG Cable and Lead Wire SystemCarefusion 2200, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK211294 Multi-Link X2 ECG Cable and Leadwire SystemVyaire Medical, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK163316 Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemCarefusion 303, Inc. · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K082851Multlink Cable and Leadwire SystemGe Medical Systems Information Technologies · 2008 · cites it directly7descendants
- K101660Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8Kepler Medtec · 2010 · cites it directly6descendants
- K162432Multi-Link X2 ECG Cable and Lead Wire SystemCarefusion 2200, Inc. · 2017 · cites it directly3descendants
- K211294Multi-Link X2 ECG Cable and Leadwire SystemVyaire Medical, Inc. · 2021 · 2 generations on1descendant
- K163316Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemCarefusion 303, Inc. · 2017 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933649 | Conmed Ecg Patient Cables and Leadwires | Conmedcorp | 1994 | — |
| 0 (this device) | K980582 | Multi-Link Cable and Lead Wire Systems | Marquette Medical Systems, Inc. | 1998 | — |
| +1 | K082851 | Multlink Cable and Leadwire System | Ge Medical Systems Information Technologies | 2008 | — |
| +1 | K101660 | Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8 | Kepler Medtec | 2010 | — |
| +1 | K162432 | Multi-Link X2 ECG Cable and Lead Wire System | Carefusion 2200, Inc. | 2017 | — |
| +2 | K211294 | Multi-Link X2 ECG Cable and Leadwire System | Vyaire Medical, Inc. | 2021 | — |
| +1 | K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System | Carefusion 303, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K933649 | Conmed Ecg Patient Cables and LeadwiresSummary page 1…ce: Multi-Link Cable and Lead Wire Systems is substantially equivalent to ConMed Corp. ECG Patient Cables and Leadwires which are currently legally marketed under 510(k) 933649. Device Description: Multi-Link Cable and Lead Wire Systems are a reusable electrode cable systems used to transmit signals from… | 1994 |
What descends from it? (10)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082851 | Multlink Cable and Leadwire System | 2008 | 7 |
| K101660 | Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8 | 2010 | 6 |
| K162432 | Multi-Link X2 ECG Cable and Lead Wire System | 2017 | 3 |
| K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System | 2017 | 1 |
| K070232 | Ecg Cables, Trunk and Patient Lead Wires | 2007 | 0 |
| K043572 | Compatibility Ecg Trunk Cables | 2005 | 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?
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?
Multi-Link Cable and Lead Wire Systems are electrode cable systems used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. Such equipment is commonly located in hospitals, doctors 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/K980582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980582: Multi-Link Cable and Lead Wire Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980582
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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