# K900461: Opus Model 4021, Vvi, 5MM Unipolar

- Pathway: 510(k) (Traditional)
- Applicant: Ela Medical, Inc.
- Decided: Mar 14, 1990 after 42 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K970072: Opus S Model 4121 and 4124 Pacemakers (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K900461
Methodology: https://510kreport.com/methodology