# K040784: Protab Ecg Tabb Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Bio Protech, Inc.
- Decided: Apr 7, 2004 after 9 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: 4 generations back to K960968 (1996). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 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.
- K030509: Skintact Ecg Tab Electrode, Leonhard Lang GmbH (2003) Summary page 1.

## Most influential descendants
- K090496: Qwiklead Reusable Electrocardiograph Electrode Patch (2009), 0 descendants of its own

## Indications for use
PROTAB ECG Tab Electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include patient ECG surveillance and ECG diagnosis recording. PROTAB ECG Tab Electrodes are non-sterile and are to be used on intact (uninjured) skin.

Source page: https://510kreport.com/device/K040784
Methodology: https://510kreport.com/methodology