510(k) · Cleared
ClearedMulti-Link X2 ECG Cable and Lead Wire System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion 2200, Inc. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Jan 18, 2017 as substantially equivalent to K980582 (Marquette Medical Systems, Inc., 1998) and 1 other predicate after a 140-day review. Its family tree reaches back 4 generations to 1994. 3 later devices descend from it.
- Decided
- Jan 18, 2017
- Review
- 140 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933649 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK933649 Conmed Ecg Patient Cables and LeadwiresConmedcorp · 1994
- 3 generations backK980582 Multi-Link Cable and Lead Wire SystemsMarquette Medical Systems, Inc. · 1998
- 2 generations backK082851 Multlink Cable and Leadwire SystemGe Medical Systems Information Technologies · 2008
- 1 generation backK101660 Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8Kepler Medtec · 2010
- This deviceK162432 Multi-Link X2 ECG Cable and Lead Wire SystemCarefusion 2200, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK211294 Multi-Link X2 ECG Cable and Leadwire SystemVyaire Medical, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK240377 LIFEPAK® ECG CablesStryker Physio-Control · 2024 · Recalled
- Descendant · cites it directly · 0 of its ownK200510 Multi-LinkTM X2 ECG Adapter and LeadwiresVyaire Medical, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See all- K211294Multi-Link X2 ECG Cable and Leadwire SystemVyaire Medical, Inc. · 2021 · cites it directly1descendant
- K240377LIFEPAK® ECG CablesStryker Physio-Control · 2024 · 2 generations on0descendants
- K200510Multi-LinkTM X2 ECG Adapter and LeadwiresVyaire Medical, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933649 | Conmed Ecg Patient Cables and Leadwires | Conmedcorp | 1994 | — |
| −3 | K980582 | Multi-Link Cable and Lead Wire Systems | Marquette Medical Systems, Inc. | 1998 | — |
| −2 | 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 | — |
| 0 (this device) | K162432 | Multi-Link X2 ECG Cable and Lead Wire System | Carefusion 2200, Inc. | 2017 | — |
| +1 | K211294 | Multi-Link X2 ECG Cable and Leadwire System | Vyaire Medical, Inc. | 2021 | — |
| +2 | K240377 | LIFEPAK® ECG Cables | Stryker Physio-Control | 2024 | 1 |
| +1 | K200510 | Multi-LinkTM X2 ECG Adapter and Leadwires | Vyaire Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 4…II Product Code: DSA 3. Predicate Device This submission demonstrates substantial equivalence to the Multi-Link Cable and Lead Wire System, K980582 was cleared on March 16, 1998. The secondary predicate device, ECG Single Patient Use Lead Wire Set, K101660 was cleared on Au… | 1998 |
| * | K101660 | Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8Summary page 4…ivalence to the Multi-Link Cable and Lead Wire System, K980582 was cleared on March 16, 1998. The secondary predicate device, ECG Single Patient Use Lead Wire Set, K101660 was cleared on August 11, 2010. This predicate device has not been subject to a design-related recall. 4. Device Description… | 2010 |
What descends from it? (3)
2 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?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 6.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K211294 (Vyaire Medical, Inc., 2021) has gone furthest, with 1 descendant 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. 2017, 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?
The Multi-Link Cable and Lead Wire System is intended to transmit ECG signals from patient electrodes to patient monitors for monitoring purposes. The Multi-Link Cable and Lead Wire System is limited to indications for use of the connected monitoring equipment. The Multi-Link trunk cables (care cables) are reusable, nonsterile and can be reprocessed. The Multi-Link lead wires are available reusable and disposable (single patient use). The Multi-Link Cable and Lead Wire System is compatible with GE Healthcare, Philips, Mindray, Spacelabs and Nihon Kohden electrocardiograph monitors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162432 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162432: Multi-Link X2 ECG Cable and Lead Wire System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162432
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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