# K220786: STAR Apollo Mapping System

- Pathway: 510(k) (Traditional)
- Applicant: Rhythm Al, Ltd.
- Decided: Dec 1, 2022 after 259 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 K001437 (2000). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201298: VX1, Volta Medical (2020) Summary page 4.

## Indications for use
STAR Apollo™ Mapping System assists users in manual annotation of 3D anatomical and electrical maps of human atria using data from multipolar, intracardiac, atrial, electrograms during atrial fibrillation. The clinical significance of utilizing the STAR Apollo Mapping System, to help identify areas with intracardiac atrial electrograms, of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

Source page: https://510kreport.com/device/K220786
Methodology: https://510kreport.com/methodology