# K102430: Tyco Electronics Electrocardiograph (Ecg) Leadwire Set

- Pathway: 510(k) (Traditional)
- Applicant: Tyco Electronics Corporation
- Decided: Sep 10, 2010 after 15 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: 7 generations back to K941811 (1994). 34 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020531: Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release a.02, Model M1275B, Philips Medical Systems (2002) Summary page 1.

## Most influential descendants
- K110287: Philips Ecg Leadwire Set (2011), 5 descendants of its own
- K142489: Unimed Disposable ECG lead wires (2014), 4 descendants of its own
- K203635: Patient Monitoring Cables (2021), 2 descendants of its own
- K240156: LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) (2024), 0 descendants of its own
- K222712: Fogg System Patient Monitoring Cables (2023), 0 descendants of its own

## Indications for use
Tyco Electronics Electrocardiograph (ECG) Leadwire Sets are indicated for use in the monitoring of cardiac signals for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.

Source page: https://510kreport.com/device/K102430
Methodology: https://510kreport.com/methodology