# K230008: Ablamap® System

- Pathway: 510(k) (Traditional)
- Applicant: Ablacon, Inc.
- Decided: Jun 8, 2023 after 156 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K000248 (2000). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203084: Ablamap Software, Ablacon, Inc. (2021) Summary page 4.
- K141185: V2.7 Software for the Labsystem Pro EP Recording System, Boston Scientific Corp (2014) Summary page 4.

## Most influential descendants
- K251344: OptiMap™ System (2025), 0 descendants of its own

## Indications for use
The Ablamap® System is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.

Source page: https://510kreport.com/device/K230008
Methodology: https://510kreport.com/methodology