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The Tracker / October 2026 / K260640

510(k) cleared

Kinetic Software Library

Monebo Technologies, Inc. · Oct 23, 2026 · K260640

FDA cleared the Kinetic Software Library from Monebo Technologies, Inc. on Oct 23, 2026 under K260640, a traditional 510(k). The device falls under product code DPS, Electrocardiograph, regulated at 21 CFR 870.2340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 27, 2026. The decision came 238 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Monebo Technologies, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260640?

K260640 is the FDA 510(k) for Kinetic Software Library, submitted by Monebo Technologies, Inc.. FDA's decision date was Oct 23, 2026, under product code DPS (Electrocardiograph).

Who makes the Kinetic Software Library?

Monebo Technologies, Inc., based in Austin, TX, is the applicant of record for K260640.

How long did the K260640 review take?

FDA received the submission on Feb 27, 2026 and issued its decision on Oct 23, 2026, 238 days later.

← All decisions in October 2026