510(k) · Cleared
ClearedEcg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kepler Medtec · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Aug 11, 2010 as substantially equivalent to K980582 (Marquette Medical Systems, Inc., 1998) and 1 other predicate after a 58-day review. Its family tree reaches back 3 generations to 1994. 6 later devices descend from it.
- Decided
- Aug 11, 2010
- Review
- 58 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K933649 (1994). 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK933649 Conmed Ecg Patient Cables and LeadwiresConmedcorp · 1994
- 2 generations backK980582 Multi-Link Cable and Lead Wire SystemsMarquette Medical Systems, Inc. · 1998
- 1 generation backK082851 Multlink Cable and Leadwire SystemGe Medical Systems Information Technologies · 2008
- This deviceK101660 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
- Descendant · 3 generations on · 0 of its ownK240377 LIFEPAK® ECG CablesStryker Physio-Control · 2024 · Recalled
- Descendant · 2 generations on · 0 of its ownK200510 Multi-LinkTM X2 ECG Adapter and LeadwiresVyaire Medical, Inc. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- 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
- K240377LIFEPAK® ECG CablesStryker Physio-Control · 2024 · 3 generations on0descendants
- K200510Multi-LinkTM X2 ECG Adapter and LeadwiresVyaire Medical, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933649 | Conmed Ecg Patient Cables and Leadwires | Conmedcorp | 1994 | — |
| −2 | 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 | — |
| 0 (this device) | 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 | — |
| +3 | K240377 | LIFEPAK® ECG Cables | Stryker Physio-Control | 2024 | 1 |
| +2 | K200510 | Multi-LinkTM X2 ECG Adapter and Leadwires | Vyaire Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 1…LASS: Class 11 PRODUCT CODE: DSA, 870.2900 Cable, transducer and electrode, patient (including connector) C) PREDICATES: K980582 Marquette Medical Systems: ECG Lead Wire and Cable System Intended use: Multi-Lint Cable and Lead Wire Systems are reusable… | 1998 |
| * | K082851 | Multlink Cable and Leadwire SystemSummary page 2…Predicate Lead Wire Set K980582 Marquette K082851I GE Medical Medical Systems: Systems: Mu… | 2008 |
What descends from it? (6)
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 16 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K162432 (Carefusion 2200, Inc., 2017) has gone furthest, with 3 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. 2010, 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 Kepler MedTec Single Patient Use ECG Lead Wire is a electrode cable system used to transmit signals from patient 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. The Single Patient Use ECG Lead Wire Set is 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/K101660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101660: Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101660
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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