# K020896: Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085 Dual-Chamber External Pulse Gene

- Pathway: 510(k) (Abbreviated)
- Applicant: Osypka Medical, Inc.
- Decided: Jun 14, 2002 after 87 days
- Product code: DTE (Pulse-Generator, Pacemaker, External)
- Device class: 2
- Regulation: 21 CFR 870.3600
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K893633 (1989). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910237: Modified Model 5330 AV Demand Pulse Generator, Medtronic Vascular (1991) Summary page 1.
- K893633: Model 5330 External a-V Sequential Demand Pulse, Medtronic Vascular (1989) Summary page 1.
- K970497: PACE 101H, Sulzer Oscor, Inc. (1997) Summary page 1.
- K923621: External Demand Pacemaker, Oscor Medical Corp. (1993) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Jun 30, 2010 · Not classified · Z-2443-2010: The recall was initiated after Osypka Medical received two (2) complaints from their Japanese distributor regarding an incompatibility of the PACE 203H with some new types of 9 V batteries. The invest
- Jun 30, 2010 · Not classified · Z-2444-2010: The recall was initiated after Osypka Medical received two (2) complaints from their Japanese distributor regarding an incompatibility of the PACE 203H with some new types of 9 V batteries. The invest

## Indications for use
The PACE 203 / PACE 203H / MODEL 3085 external pulse generator / temporary pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular or A-V sequential pacing. The PACE 203 / PACE 203H / MODEL 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes. Specific indications include, but are not limited to, the following: Sick Sinus Syndrome; Bradycardia with congestive heart failure; Complete heart block; Acute myocardial infarction complicated by heart block; Sinus bradycardia; Cardiac arrest with ventricular asystole; Atrial and/or ventricular ectopic arrhythmia; Postoperatively after cardiac surgery; Temporary application during implantation or exchange of permanent pacemaker. Indication for atrial overdrive stimulation (rapid atrial pacing): Supra-ventricular tachycardia. The PACE 203 / PACE 203H / MODEL 3085 can be used to measure atrial or ventricular voltage stimulation thresholds and determine the approximate P wave potentials sensed via the atrial pacing lead electrodes and the approximate R wave potentials sensed via the ventricular pacing lead electrodes. The XI.TME and XI.RAC Extension Cables are used with external pulse generators / temporary cardiac pacemakers and pacing system analyzers.

Source page: https://510kreport.com/device/K020896
Methodology: https://510kreport.com/methodology