# K090496: Qwiklead Reusable Electrocardiograph Electrode Patch

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Lead Technologies, Inc.
- Decided: Sep 1, 2009 after 188 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: 5 generations back to K960968 (1996). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020003: Electrocardiograph (Ecg) Electrode, Non-Sterile, Bio Protech, Inc. (2002) Summary page 1.
- K073104: Skintact and Various Other Tradenames, Leonhard Lang GmbH (2007) Summary page 1.
- K040784: Protab Ecg Tabb Electrode, Bio Protech, Inc. (2004) Summary page 1.

## Indications for use
The Qwiklead T M Electrocardiograph Electrode Patch is intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include, in particular, patient ECG surveillance and ECG diagnosis.recording. The Qwiklead T M Electrocardiograph Electrode Patch is intended for single-patient/single application use and is intended to be used on intact (uninjured) skin. The Qwiklead T M Electrocardiograph Electrode Patch is to be used on adults.

Source page: https://510kreport.com/device/K090496
Methodology: https://510kreport.com/methodology