Cleared Traditional

NanoPress 760A-BT (760A-BT)

K254267 · Mego Afek , Ltd. · Cardiovascular
Feb 2026
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K254267 is an FDA 510(k) clearance for the NanoPress 760A-BT (760A-BT), a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Mego Afek , Ltd. (Kibbuts Afek, IL). The FDA issued a Cleared decision on February 24, 2026, 56 days after receiving the submission on December 30, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K254267 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2025
Decision Date February 24, 2026
Days to Decision 56 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code JOW — Sleeve, Limb, Compressible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5800

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