510(k) K253733— STAR Apollo Mapping System

Substantially Equivalent

Rhythm AI, Ltd.

Clearance details

Applicant: Rhythm AI, Ltd.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2025-11-24
Decision date: 2025-12-19
Decision: Substantially Equivalent
Clearance type: Special
Location: London, GB

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.