# K970497: PACE 101H

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Oscor, Inc.
- Decided: Jun 4, 1997 after 114 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K020896: Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085 Dual-Chamber External Pulse Gene (2002), 2 descendants of its own
- K022939: Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and Accessories,Cardiotronic Pace 101 and Accessories (2002), 1 descendant of its own
- K033130: Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse Generator (2003), 0 descendants of its own

## Indications for use
Thie external pacemaker PACE 101 H is designed for temporary stimulation of the heart in case of thythm disturbances and conduction defects. According to present clinical experience, the instrument is especially suited for stimulation of the heart in the following cases: e treatment of pzfiehls before an operation, whereby an implantable pacemaker is being inserted; e treatment of tachyarrhythmia; * treatment of special cases of acute myocardial infarction; e treatment of patients after heart surgery.

Source page: https://510kreport.com/device/K970497
Methodology: https://510kreport.com/methodology