# K232261: TME Temporary Myocardial Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Osypka AG
- Decided: Apr 26, 2024 after 270 days
- Product code: LDF (Electrode, Pacemaker, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K850622 (1985). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850622: Oscor Medical Model Tme 64S Bipolar Temp/Heart Wir, Oscor Medical Corp. (1985) Summary page 5.

## Indications for use
OSYPKA TME Temporary Myocardial Electrodes are intended for temporary cardiac pacing and sensing of the cardiac chambers after cardiac surgery to prevent postoperative bradycardia and conduction disorders.

Source page: https://510kreport.com/device/K232261
Methodology: https://510kreport.com/methodology