# K983196: Padtak Pace/Defib/Cardiovert Monitoring Electrode (S)

- Pathway: 510(k) (Traditional)
- Applicant: Tz Medical, Inc.
- Decided: Sep 15, 1999 after 369 days
- Product code: DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive))
- Device class: 2
- Regulation: 21 CFR 870.5550
- 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’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Apr 30, 2013 · Class II · Z-1438-2013: TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may contain a defective white wire on the connector assembl

## Indications for use
TZ Medical adult disposable electrodes are used by trained professionals in hospitals, doctors offices and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.

Source page: https://510kreport.com/device/K983196
Methodology: https://510kreport.com/methodology