# K011980: Adapter, Pacing Analyzer/Universal Pacing Adapter, Models 4820 and 4825

- Pathway: 510(k) (Traditional)
- Applicant: Pace Medical
- Decided: Sep 12, 2001 after 79 days
- Product code: DTE (Pulse-Generator, Pacemaker, External)
- Device class: 2
- Regulation: 21 CFR 870.3600
- Recalls of this device: none
- 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.

## Indications for use
For use in converting collet terminal outputs of pacing devices equipped with - terminals spaced 1.25" on centers so they will connect to extension cables and pacing leads having 2mm HCK protected pin connectors.

Source page: https://510kreport.com/device/K011980
Methodology: https://510kreport.com/methodology