# K914109: Pikos 01 & Pikos E 01

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, GmbH & Co.
- Decided: Feb 26, 1992 after 166 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K945627: Pikos LP 01, Pikos LP E01 (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K914109
Methodology: https://510kreport.com/methodology