510(k) · Cleared
ClearedMulti-Link X2 ECG Adapter and Direct Connect Lead Wire System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion 303, Inc. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Jun 22, 2017 as substantially equivalent to K980582 (Marquette Medical Systems, Inc., 1998) and 1 other predicate after a 211-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- Jun 22, 2017
- Review
- 211 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933649 (1994). 1 later device descends from it, 1 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 deviceK163316 Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemCarefusion 303, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK191273 Multi-Link X2 ECG and SpO2 AdapterVyaire Medical, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K191273Multi-Link X2 ECG and SpO2 AdapterVyaire Medical, Inc. · 2019 · 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) | K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System | Carefusion 303, Inc. | 2017 | — |
| +1 | K191273 | Multi-Link X2 ECG and SpO2 Adapter | Vyaire Medical, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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…21 CFR 870.2900 Regulatory Class: II Product Code: DSA 3. Predicate Device Multi-Link Cable and Lead Wire Systems cleared under K980582 on March 16, 1998, and secondary predicate device, ECG Single Patient Use Lead Wire Set, cleared under K101660 on August 11… | 1998 |
| * | K101660 | Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8Summary page 4…Multi-Link Cable and Lead Wire Systems cleared under K980582 on March 16, 1998, and secondary predicate device, ECG Single Patient Use Lead Wire Set, cleared under K101660 on August 11, 2010. These predicate devices have not been subject to a design-related recall. 4. Device Description The… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191273 | Multi-Link X2 ECG and SpO2 Adapter | 2019 | 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?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 6.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K191273 (Vyaire Medical, Inc., 2019) has gone furthest, with 0 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. 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™ X2 ECG Adapter and Direct Connect Lead Wire System are used in telemetry to transmit ECG signals from the electrodes to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. The Multi-Link Direct Connect Lead Wires are single-patient-use, non-sterile and cannot be reprocessed. The Multi-Link Adapters are reusable, non-sterile and can be reprocessed. The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System are used with any patient population requiring ambulatory ECG, and are compatible with Philips, Mindray and Nihon Kohden electrocardiograph monitors.
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/K163316 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163316: Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163316
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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