# K923026: Pikos 01-a and Pikos E01-a Implantable Pacemaker

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, GmbH & Co.
- Decided: Aug 19, 1993 after 422 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
- K993434: Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-a, Pikos E01-a (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K923026
Methodology: https://510kreport.com/methodology