# K033130: Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse Generator

- Pathway: 510(k) (Special)
- Applicant: Osypka Medical, Inc.
- Decided: Oct 31, 2003 after 31 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
Longest line of descent: 3 generations back to K893633 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022939: Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and Accessories,Cardiotronic Pace 101 and Accessories, Osypka Medical, Inc. (2002)
- K970497: PACE 101H, Sulzer Oscor, Inc. (1997) Summary page 1.
- K923621: External Demand Pacemaker, Oscor Medical Corp. (1993) Summary page 1.
- K020896: Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085 Dual-Chamber External Pulse Gene, Osypka Medical, Inc. (2002)

## Indications for use
The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular pacing. When combined with a stimulation lead system, the PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator can be used whenever temporary atrial or ventricular pacing is indicated. The device can be employed for therapeutic as well as diagnostic purposes or may be used prophylactically. Specific indications for temporary pacing include, but are not limited to: Complete (third-degree) or intermittent heart block; Symptomatic sinus bradycardia; Atrial and/or ventricular ectopic arrhythmia; Sick Sinus Syndrome (SSS); Atrial tachyarrhythmia; Acute myocardial infarction-induced heart block; Stimulation during ventricular asystole; Use duiing the replacement of an implantable pulse generator; Stimulation and monitoring before the implantation of a cardiac pulse generator; Stimulation and monitoring following heart surgery.

Source page: https://510kreport.com/device/K033130
Methodology: https://510kreport.com/methodology