# K160260: Tempo Temporary Pacing Lead

- Pathway: 510(k) (Traditional)
- Applicant: Biotrace Medical, Inc.
- Decided: Oct 25, 2016 after 267 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 K042190 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042190: Model 6416 Temporary Pacing Lead System, Medtronic Vascular (2004) Summary page 5.

## Most influential descendants
- K252042: Sync AV II Temporary Pacing Catheter (2026), 0 descendants of its own

## Indications for use
The BioTrace Medical Tempo Temporary Pacing Lead is indicated for use in temporary intracardiac pacing for a maximum of seven (7) days and is designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

Source page: https://510kreport.com/device/K160260
Methodology: https://510kreport.com/methodology