# K071576: Textronics Ecg Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Textronics, Inc.
- Decided: Nov 2, 2007 after 147 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: 3 generations back to K863116 (1986). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944497: Unilect, Monitab and Biotrace-HR, Msb, Ltd. (1996) Summary page 2.
- K945479: Medi-Trace (R) 500 Ecg Electrode, Graphic Controls Corp. (1995) Summary page 2.
- K043361: Accuheart Electrode Belt, Advanced Bioelectric Corporation (2005) Summary page 2.

## Indications for use
The TextronicsTM ECG Electrode is intended for use in general electrocardiograph monitoring and recording procedures. The TextronicsTM ECG Electrode is indicated for use with most ECG instruments on the market. It is indicated applications including resting ECGs, exercise ECGs, and/or ambulatory monitoring.

Source page: https://510kreport.com/device/K071576
Methodology: https://510kreport.com/methodology