510(k) · Cleared
ClearedMultlink Cable and Leadwire System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Nov 19, 2008 as substantially equivalent to K980582 (Marquette Medical Systems, Inc., 1998) after a 51-day review. Its family tree reaches back 2 generations to 1994. 7 later devices descend from it.
- Decided
- Nov 19, 2008
- Review
- 51 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K933649 (1994). 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK933649 Conmed Ecg Patient Cables and LeadwiresConmedcorp · 1994
- 1 generation backK980582 Multi-Link Cable and Lead Wire SystemsMarquette Medical Systems, Inc. · 1998
- This deviceK082851 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 · 2 generations on · 3 of its ownK162432 Multi-Link X2 ECG Cable and Lead Wire SystemCarefusion 2200, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK211294 Multi-Link X2 ECG Cable and Leadwire SystemVyaire Medical, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK163316 Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemCarefusion 303, Inc. · 2017
- Descendant · 4 generations on · 0 of its ownK240377 LIFEPAK® ECG CablesStryker Physio-Control · 2024 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- 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 · 2 generations on3descendants
- K211294Multi-Link X2 ECG Cable and Leadwire SystemVyaire Medical, Inc. · 2021 · 3 generations on1descendant
- K163316Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemCarefusion 303, Inc. · 2017 · 2 generations on1descendant
- K240377LIFEPAK® ECG CablesStryker Physio-Control · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933649 | Conmed Ecg Patient Cables and Leadwires | Conmedcorp | 1994 | — |
| −1 | K980582 | Multi-Link Cable and Lead Wire Systems | Marquette Medical Systems, Inc. | 1998 | — |
| 0 (this device) | 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 | — |
| +2 | K162432 | Multi-Link X2 ECG Cable and Lead Wire System | Carefusion 2200, Inc. | 2017 | — |
| +3 | K211294 | Multi-Link X2 ECG Cable and Leadwire System | Vyaire Medical, Inc. | 2021 | — |
| +2 | K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System | Carefusion 303, Inc. | 2017 | — |
| +4 | K240377 | LIFEPAK® ECG Cables | Stryker Physio-Control | 2024 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K980582 | Multi-Link Cable and Lead Wire SystemsSummary page 1…Patient transducer andDS electrode cable Predicate Device(s): Multilink Cable and Leadwire Systems (K980582) Device Description: The purpose and function of the device has not changed The Multili… | 1998 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101660 | Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8 | 2010 | 6 |
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K101660 (Kepler Medtec, 2010) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K980582.
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. 2008, this device’s year, is highlighted.
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 electrocardiograph 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.
Multilink Cables and Lead Wire Systems are intended to be used by trained operators in a medical professional's environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082851: Multlink Cable and 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/K082851
Report an extraction error
Are you the manufacturer?
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