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Zener (model ZEN-001-B1)

by Uvx, Inc.

510(k) K252128

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK252128 Date15 Sep 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FRA
Device Class
Class II
Regulation
21 CFR Part 880.6500
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Zener (model ZEN-001-B1) is an ultraviolet (UV) air purifying device intended for the reduction of bacteria in air in medical facilities. It has demonstrated the ability to reduce Klebsiella aerogenes in air by 4.73 net log-reduction at 50% ± 10% relative humidity and 23°C ± 3°C (73°F ± 5°F).

The device is non-sterile and is supplied by Uvx, Inc. It is authorized under FDA 510(k) with regulation number 21 CFR 880.6500 and product code FRA. The device is classified as Class II and received FDA clearance on September 15, 2025.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Zener UV air purifier used for?

    The Zener (model ZEN-001-B1) is an ultraviolet air purifying device designed for the reduction of bacteria in air within medical facilities. It specifically demonstrated a 4.73 net log-reduction of Klebsiella aerogenes under controlled conditions.

  • How is the Zener UV air purifier supplied?

    The Zener UV air purifier is supplied by Uvx, Inc. It is non-sterile and comes as a single unit, though the device is intended for repeated use in medical environments to maintain air quality.

  • What regulatory approvals does the Zener UV air purifier have?

    The Zener UV air purifier is authorized under FDA 510(k) with regulation number 21 CFR 880.6500 and product code FRA. It is classified as Class II and received FDA clearance on September 15, 2025.

  • What are the optimal conditions for the Zener UV air purifier's performance?

    The Zener UV air purifier demonstrates its maximum effectiveness at 50% ± 10% relative humidity and 23°C ± 3°C (73°F ± 5°F). These conditions were used during testing to achieve the 4.73 net log-reduction of Klebsiella aerogenes.