# K945627: Pikos LP 01, Pikos LP E01

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Mar 4, 1996 after 474 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 K914109 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914109: Pikos 01 & Pikos E 01, Biotronik, GmbH & Co. (1992) Summary page 1.

## Indications for use
The Pikos LP 01/LP BO1 models, like the Pikos 01/B01 models, are indicated for use in the following conditions: Sinus node arrest or bradycardia with or without AV conduction disorder. Intermittent or complete AV conduction block. Brady/tachy syndromeorothermanifedafionofsicksinunyndromcwhichmfltsin Atrial fibrillation and ventricular bradyarrhythmia.

Source page: https://510kreport.com/device/K945627
Methodology: https://510kreport.com/methodology