K250415 is an FDA 510(k) clearance for the G0 Blood Pressure Monitoring System (G0). Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.
Submitted by Aktiia SA (Neuchatel, CH). The FDA issued a Cleared decision on July 2, 2025 after a review of 139 days - within the typical 510(k) review window.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.
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NCT06565780
Completed
Interventional
Industry-sponsored
Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring Device At Wrist Against Double Auscultation
Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring (OBPM) Device At Wrist Against Double Auscultation: a Multicentric Prospective Clinical Study
| Condition studied |
Hypertension |
| Study design |
Single group |
| Eligibility |
All sexes
· 22 Years+
· Healthy volunteers accepted
|
| Sponsor |
Aktiia SA
(industry)
|
Started 2024-09-23
→
Primary completion 2025-01-10
Primary outcome
Blood pressure mean value of differences
Secondary outcome
Heart rate root-mean-square error
Study completed - no results published.
This trial concluded in 2025 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov