510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250415Substantially Equivalent

G0 Blood Pressure Monitoring System (G0)

Aktiia SA, Neuchatel, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250415 is the FDA 510(k) clearance record for G0 Blood Pressure Monitoring System (G0), a class II device, cleared for Aktiia SA on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list one 510(k) clearance for Aktiia SA. As of , FDA records show no recalls naming K250415.

Clearance record

Decision date
Received
(139 days to decision)
Product code
DXN System, Measurement, Blood-Pressure, Non-Invasive
Regulation
21 CFR 870.1130
Device class
Class II
Review panel
Cardiovascular
Applicant
Aktiia SA Rue Du Bassin 8a, Neuchatel, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXN

Trailing 12 months
29 clearances under product code DXN in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DXN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20264
March 20262
April 20265
May 20263
June 20264
July 20262
August 20264
September 20262
October 20260