# K203084: Ablamap Software

- Pathway: 510(k) (Traditional)
- Applicant: Ablacon, Inc.
- Decided: Aug 31, 2021 after 322 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: 8 generations back to K000248 (2000). 15 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171583: RhythmView Workstation, Abbott Electrophysiology (2017) Summary page 4.

## Most influential descendants
- K230008: Ablamap® System (2023), 1 descendant of its own
- K251344: OptiMap™ System (2025), 0 descendants of its own

## Indications for use
The Ablamap® Software 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/K203084
Methodology: https://510kreport.com/methodology