# K935371: R2 Pads, R2 Cath Pads, R2 Pace Pads, R2 Dispersive Pad

- Pathway: 510(k) (Traditional)
- Applicant: R2 Medical Systems
- Decided: Dec 2, 1994 after 389 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 18, 2006 · Not classified · Z-1242-06: The tinfoil in the triangle electrodes has the potential to develop cracks which may hinder electrical flow and product performance during defibrillation.

Source page: https://510kreport.com/device/K935371
Methodology: https://510kreport.com/methodology