# K101660: Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8

- Pathway: 510(k) (Traditional)
- Applicant: Kepler Medtec
- Decided: Aug 11, 2010 after 58 days
- Product code: DSA (Cable, Transducer And Electrode, Patient, (Including Connector))
- Device class: 2
- Regulation: 21 CFR 870.2900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K933649 (1994). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980582: Multi-Link Cable and Lead Wire Systems, Marquette Medical Systems, Inc. (1998) Summary page 1.
- K082851: Multlink Cable and Leadwire System, Ge Medical Systems Information Technologies (2008) Summary page 2.

## Most influential descendants
- K162432: Multi-Link X2 ECG Cable and Lead Wire System (2017), 3 descendants of its own
- K211294: Multi-Link X2 ECG Cable and Leadwire System (2021), 1 descendant of its own
- K163316: Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System (2017), 1 descendant of its own
- K240377: LIFEPAK® ECG Cables (2024), 0 descendants of its own
- K200510: Multi-LinkTM X2 ECG Adapter and Leadwires (2020), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K101660
Methodology: https://510kreport.com/methodology