# K980806: Affinity Medical Patient Cable System

- Pathway: 510(k) (Traditional)
- Applicant: Affinity Medical Technologies, LLC
- Decided: Mar 25, 1998 after 22 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: 1 generation back to K952659 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952659: Tronomate Patient Cable & Leadwire System, Tronomed, Inc. (1996) Summary page 1.

## Indications for use
The Affinity Medical Patient Cable Systems are intended to transmit data in the form of electrocardiographic signals from patient ECG electrode pads to ECG monitors.

Source page: https://510kreport.com/device/K980806
Methodology: https://510kreport.com/methodology