FDA 510(k) · Aktiia / Hilo
K250415: G0 Blood Pressure Monitoring System (G0) (Aktiia SA)
Aktiia SA received FDA 510(k) K250415 for G0 Blood Pressure Monitoring System (G0), with a decision date of Jul 2, 2025 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K250415 |
|---|---|
| Pathway | 510(k) |
| Applicant | Aktiia SA |
| Device name | G0 Blood Pressure Monitoring System (G0) |
| Product code | DXN: System, Measurement, Blood-Pressure, Non-Invasive |
| Regulation (21 CFR) | 870.1130 |
| Device class | Class 2 |
| Date received | Feb 13, 2025 |
| Decision date | Jul 2, 2025 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Aktiia GO Blood pressure monitoring system consists of a wrist worn monitor and an oscillometric cuff. The system is intended for measuring blood pressure and pulse rate based on using a Pulse Wave technique in adults aged from 22 to 59 years old with wrist circumference ranging from 14 cm to 21 cm following a calibration process (every 24 hours) using the oscillometric blood pressure cuff. The Aktiia GO Blood pressure monitoring system is intended for spot-checking of adult patients for home use.
Extracted automatically from FDA's 510(k) summary with OCR. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K250415
- K254000 Happy Health Blood Pressure Monitor (Happy Health, Sep 3, 2026, DXN)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DXN is "System, Measurement, Blood-Pressure, Non-Invasive", class 2, 21 CFR 870.1130.
Our labels for filtering: claim Blood pressure, sensor Wrist PPG. These are heuristics, not FDA fields.