# K242863: Bioptimal Bipolar Pacing Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bioptimal International Pte., Ltd.
- Decided: Jun 15, 2025 after 268 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: 2 generations back to K914185 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161873: Pacel Flow Directed Pacing Catheter, St Jude Medical (2016) Summary page 5.

## Indications for use
Bioptimal Bipolar Pacing Catheters are indicated for use in temporary, transvenous, right ventricular pacing.

Source page: https://510kreport.com/device/K242863
Methodology: https://510kreport.com/methodology