# K911122: 8MM Quantum Pulse/Suprima II Pulse Generators

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics, Inc.
- Decided: May 16, 1991 after 65 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
- K023205: Elox P 45-BP; Elox P 53-BP; Elox P 60-BP (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K911122
Methodology: https://510kreport.com/methodology