# K181726: Medline Patient Cables and Lead Wires

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Sep 20, 2018 after 83 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: 2 generations back to K942321 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081762: Curbell Patient Monitoring Cables, Curbell Electronics, Inc. (2008) Summary page 4.

## Most influential descendants
- 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 (2025), 0 descendants of its own

## Indications for use
Medline Patient Cables and Lead Wires are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional. Additionally, the use of Medline Patient Cables and Lead Wires is limited by the indications for use of the ECG monitoring or diagnostic equipment it is connected to. Medline Patient Cables and Lead Wires are intended for Prescription Use only.

Source page: https://510kreport.com/device/K181726
Methodology: https://510kreport.com/methodology