| K-number | K242447 |
| Device name | Falcon HST |
| Applicant | Compumedics Limited |
| Product code | OLV |
| Device class | Class II |
| Decision date | Feb 20, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 882.1400 |
The Falcon HST is an EEG and respiratory signal recorder intended for use by adult patients in home or clinical settings, under qualified healthcare practitioner direction, to aid in diagnosing sleep disorders. It records EEG, EOG, ECG, respiratory effort, airflow, body position, and pulse oximetry signals for analysis of sleep-related breathing and cardiac disorders.
The Falcon HST uses identical EEG hardware to the predicate Zmachine Synergy and similar pressure transducers for airflow sensing. Key differences include: Falcon HST adds an abdominal effort belt (Zmachine Synergy has only thoracic), Falcon HST has a color touchscreen and charging cradle (Zmachine Synergy has single button and USB cable), Falcon HST records 4 EEG channels (Zmachine Synergy records 1), and Falcon HST uses USB-C with onboard memory (Zmachine Synergy uses USB with fixed microSD card).
IEC 60601-1:2005 (electrical safety), IEC 60601-1-2:2014 and EN 60601-1-2:2015 (EMC), IEC 60601-1-11:2015 (mechanical/environmental), IEC 80601-2-26:2019 (electroencephalograph safety and performance), IEC 60601-2-47:2012 (ambulatory electrocardiography), and IEC 62133-2:2017 (lithium batteries). Bench comparison testing was performed against Zmachine Synergy.
Substantial equivalence is supported because both devices share identical EEG acquisition hardware, use the same sensing principles for all physiological parameters (pressure transducers for airflow, accelerometers for position, pulse oximetry modules), and have identical intended use for sleep disorder diagnosis in home/clinical settings. Side-by-side bench testing demonstrated substantially equivalent performance across all measured channels (EEG, respiratory effort, airflow, body position, pulse oximetry), with all measured values in high agreement. The Falcon HST's additional abdominal effort belt and increased EEG channels represent enhancements rather than changes that raise new safety concerns, and all design and performance testing met or exceeded requirements equivalent to the predicate device.
View the full FDA submission: accessdata.fda.gov