# K080112: Patient Cable

- Pathway: 510(k) (Traditional)
- Applicant: Med-Dyne
- Decided: Jun 20, 2008 after 156 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Aug 1, 2019 · Class II · Z-2553-2019: The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.

## Indications for use
The cables are used to transfer monitoring signals from a patient's electrodes, which are connected to leadwires, to a patient's monitor, resulting in no direct contact with the patient. While medical personnel observe the patient, information is received through the cables and is displayed on the monitor. This information can then be used by medical personnel to assess the patient and determine the proper course of medical action.

Source page: https://510kreport.com/device/K080112
Methodology: https://510kreport.com/methodology