# K110287: Philips Ecg Leadwire Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems
- Decided: Feb 15, 2011 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K941811 (1994). 35 ancestors in all.
5 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)
- K102430: Tyco Electronics Electrocardiograph (Ecg) Leadwire Set, Tyco Electronics Corporation (2010) Summary page 2.

## Most influential descendants
- 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
- K153188: Caremed patient cable and leadwires (2016), 0 descendants of its own

## Recalls of this device
- Jul 19, 2019 · Class II · Z-2495-2019: The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. which may prevent or impede the performance of I 2-Lead ECG measurements.

## Indications for use
Philips ECG leadsets 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/K110287
Methodology: https://510kreport.com/methodology