# K153188: Caremed patient cable and leadwires

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Caremed Medical Technology Co., Ltd.
- Decided: Oct 24, 2016 after 356 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: 10 generations back to K941811 (1994). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142489: Unimed Disposable ECG lead wires, Unimed Medical Supplies, Inc. (2014) Summary page 4.

## Indications for use
The subject device is intended for use only by trained healthcare professionals for measurement of a patient's ECG 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/K153188
Methodology: https://510kreport.com/methodology