# K962115: Cambridge Heart HI-Res Ecg Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Cambridge Heart, Inc.
- Decided: Aug 29, 1996 after 90 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- 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 K782079 (1979). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K791006: Smart Bilectrodes, Electronics For Medicine, Inc. (1979) Summary page 1.
- K782079: Electrode System, Quik-Prep, Quinton, Inc. (1979) Summary page 1.
- K821438: Red Dot Monitoring Electrodes #2260/65, 3M Company (1982) Summary page 1.
- K882609: Models M1175A & M1176A Component Monitoring System, Waltham Div. Hewlett Packard (1989) Summary page 4.

## Most influential descendants
- K013615: Micro-Induction 1000 System (2002), 1 descendant of its own
- K090249: Modification to: Micro-Induction 1000 System (2009), 0 descendants of its own

## Indications for use
The Cambridge Heart Hi-Res™ ECG Electrode is intended for short term use to measure electrocardiogram signals at rest and during ECG stress testing with the CH 2000 Stress Test System and successor systems. This device is supplied non-sterile and is intended for one time use only.

Source page: https://510kreport.com/device/K962115
Methodology: https://510kreport.com/methodology