# K993434: Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-a, Pikos E01-a

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Nov 10, 1999 after 29 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K923026: Pikos 01-a and Pikos E01-a Implantable Pacemaker, Biotronik, GmbH & Co. (1993) Summary page 1.

## Cited in the summary but kept off the family tree
- K914193: A&E Medical Corp Dispos Suct Coag W/Non Stick Coat, Alto Development Corp. (1992). Our OCR of the scanned summary read K914193, FDA’s number for A&E Medical Corp Dispos Suct Coag W/Non Stick Coat (Alto Development Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Pikos 01-B”. Kept off the family tree. Summary page 1.

## Indications for use
Pikos single chamber pacemakers, Models 01/01-A/E01/LP 01/LP E01/E01-B pacemakers are indicated for the following: Symptomatic paroxysmal or permanent second or third-degree AV block Symptomatic bilateral bundle branch block Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias Vasovagal syndromes or hypersensitive carotid sinus syndromes

Source page: https://510kreport.com/device/K993434
Methodology: https://510kreport.com/methodology