Cleared Traditional

Zener? (model ZEN-001-B1)

K252128 · Uvx, Inc. · General Hospital
Sep 2025
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K252128 is an FDA 510(k) clearance for the Zener? (model ZEN-001-B1), a Purifier, Air, Ultraviolet, Medical (Class II — Special Controls, product code FRA), submitted by Uvx, Inc. (Vancouver, CA). The FDA issued a Cleared decision on September 15, 2025, 70 days after receiving the submission on July 7, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6500.

Submission Details

510(k) Number K252128 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2025
Decision Date September 15, 2025
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRA — Purifier, Air, Ultraviolet, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6500