# K970072: Opus S Model 4121 and 4124 Pacemakers

- Pathway: 510(k) (Traditional)
- Applicant: Ela Medical, Inc.
- Decided: Aug 29, 1997 after 233 days
- Product code: DXY (Implantable Pacemaker Pulse-Generator)
- Device class: 3
- Regulation: 21 CFR 870.3610
- 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 K882391 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900461: Opus Model 4021, Vvi, 5MM Unipolar, Ela Medical, Inc. (1990) Summary page 1.
- K952363: Opus Pacemakers (Models 4021, 4033, and 4034), Ela Medical, Inc. (1995) Summary page 1.
- K882391: Opus 3 Pulse Generators Models 4003,4004,4023,4024, Ela Medical, Inc. (1988) Summary page 1.
- K952364: Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024), Ela Medical, Inc. (1995) Summary page 1.

## Indications for use
AV conduction disorders or intraventricular paroxysmal/permanent conduction disorders with permanent atrial tachycardia: atrial fibrillation or flutter (lead implanted in the ventricle), Sinus bradycardia, sinoatrial block, brady-tachy syndrome without atrioventricular conduction disorder (lead implanted in the atrium).

Source page: https://510kreport.com/device/K970072
Methodology: https://510kreport.com/methodology