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The Tracker / August 2026 / K260242

510(k) cleared

CPETWise Platform

Medibyt , Ltd. · Aug 20, 2026 · K260242 · In the directory

FDA cleared the CPETWise Platform from Medibyt , Ltd. on Aug 20, 2026 under K260242, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code BTY, Calculator, Predicted Values, Pulmonary Function, regulated at 21 CFR 868.1890 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jan 26, 2026. The decision came 206 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 Medibyt , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260242?

K260242 is the FDA 510(k) for CPETWise Platform, submitted by Medibyt , Ltd.. FDA's decision date was Aug 20, 2026, under product code BTY (Calculator, Predicted Values, Pulmonary Function).

Who makes the CPETWise Platform?

Medibyt , Ltd., based in Yakum, is the applicant of record for K260242. The company is listed in the MedDevice Startups directory.

How long did the K260242 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on Aug 20, 2026, 206 days later.

← All decisions in August 2026

Sources

In the startup directory

Medibyt

Digital Health & SaMD · Yakum, Israel