Falcon HST

K242447

Compumedics Limited · cleared 2025-02-20 · product code OLV · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The Falcon HST comprises hardware and software which provide separate parameters for recording, review, and analysis of collected and stored physiological parameters, including EEG, EOG, ECG and respiratory signals, which are then used as an aid in the diagnosis of respiratory and/or cardiac related sleep disorders by qualified physicians.”
AlgorithmProprietary adaptive algorithm using time and frequency domain features
source quote (p.9)
“Proprietary adaptive algorithm using time and frequency domain features”
Adaptive (vs locked)Yes
source quote (p.9)
“Proprietary adaptive algorithm using time and frequency domain features”
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: EEG characteristics were found to be in high agreement with the design limits for all points of comparison.; EEG recording capabilities were found to be substantially equivalent.; Respiratory Effort characteristics were found to be substantially equivalent.; Respiratory Airflow characteristics were found to be substantially equivalent.; Body Position recording capabilities were found to be substantially equivalent.; The heart rate and oxygen saturation readings were found to be in high agreement when comparing the two systems together.; The Pulse Oximeter recording capabilities were found to be substantially equivalent.

standards: IEC 60601-1:2005 (Third Edition) + COR1:2006 + COR2:2007 + A1:2012 + A2:2020), IEC 60601-1-2:2014 + A1:2020, EN 60601-1-2:2015+A1:2021), IEC 60601-1-11:2015+A1:2020), IEC 80601-2-26:2019, IEC 60601-2-47:2012, IEC 62133-2:2017/AMD1:2021

Retrospective clinical

sample size not stated

endpoints: calculating the apnea hypopnea index (AHI); sleep staging (N1, N2, N3, REM and Wake)

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
2
MAUDE reports in code, 12mo
+20%
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Neurology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K242447