510(k) · Cleared
ClearedMulti-Link X2 ECG and SpO2 Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vyaire Medical, Inc. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Sep 13, 2019 as substantially equivalent to K163316 (Carefusion 303, Inc., 2017) after a 123-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Sep 13, 2019
- Review
- 123 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K933649 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK933649 Conmed Ecg Patient Cables and LeadwiresConmedcorp · 1994
- 4 generations backK980582 Multi-Link Cable and Lead Wire SystemsMarquette Medical Systems, Inc. · 1998
- 3 generations backK082851 Multlink Cable and Leadwire SystemGe Medical Systems Information Technologies · 2008
- 2 generations backK101660 Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8Kepler Medtec · 2010
- 1 generation backK163316 Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemCarefusion 303, Inc. · 2017
- This deviceK191273 Multi-Link X2 ECG and SpO2 AdapterVyaire Medical, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933649 | Conmed Ecg Patient Cables and Leadwires | Conmedcorp | 1994 | — |
| −4 | K980582 | Multi-Link Cable and Lead Wire Systems | Marquette Medical Systems, Inc. | 1998 | — |
| −3 | K082851 | Multlink Cable and Leadwire System | Ge Medical Systems Information Technologies | 2008 | — |
| −2 | K101660 | Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8 | Kepler Medtec | 2010 | — |
| −1 | K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System | Carefusion 303, Inc. | 2017 | — |
| 0 (this device) | K191273 | Multi-Link X2 ECG and SpO2 Adapter | Vyaire Medical, Inc. | 2019 | — |
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.
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- None of the 5 ancestors has a recall.
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. 2019, 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 Lead Wire System are used in telemetry to transmit ECG and/or SpO2-signals from the electrodes and sensors to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. The Multi-Link Adapters are reusable, nonsterile and can be reprocessed. The Multi-Link X2 ECG Adapter and Lead Wire System are used with any patient population requiring ambulatory monitoring, and are compatible with the Philips MX40 electrocardiograph monitor.
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/K191273 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191273: Multi-Link X2 ECG and SpO2 Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191273
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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