# K243545: Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC;  989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC;  M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m;  M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m;  M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m;  M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m;  M1663A,10 Lead ECG Trunk AAMI/IEC 2m;  M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m;  M1671A, 3 Leadset, Grabber, AAMI, ICU;  M1673A, 3 Leadset, Sn

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medizin Systeme Böblingen GmbH
- Decided: Jan 17, 2025 after 63 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 K942321 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181726: Medline Patient Cables and Lead Wires, Medline Industries, Inc. (2018) Summary page 6.

## Indications for use
Philips IntelliVue reusable ECG lead sets/trunk cables and Philips OR ECG trunk cables are indicated for continuous monitoring of cardiac signals for both diagnostic and monitoring purposes. These devices are limited by the indications for use of the connected monitoring and diagnostic equipment in healthcare facilities. These devices are intended to interact with patient intact skin only.

Source page: https://510kreport.com/device/K243545
Methodology: https://510kreport.com/methodology