CPETWise Platform— 510(k) K260242

Name: FDA 510(k) clearance K260242
Creator: U.S. Food and Drug Administration
Published: 2026-08-20

Substantially Equivalent

Medibyt , Ltd.

FDA 510(k) clearance K260242 for CPETWise Platform, Substantially Equivalent on 2026-08-20. Applicant: Medibyt , Ltd.. Device class: 2.

Summary

Medibyt's CPETWise Platform is filed under product code BTY, pulmonary function predicted values calculators. The record doesn't expand CPET or describe the platform further.

Class II, 21 CFR 868.1890. Anesthesiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Medibyt filed from Yakum, Israel. The decision came 206 calendar days after receipt (January 26 to August 20, 2026), and it was substantially equivalent. The record flags it as a third-party review.

Clearance details

Applicant: Medibyt , Ltd.
Product code: Product code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2026-01-26
Decision date: 2026-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yakum, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.