FDA 510(k)

Zener® (model ZEN-001-B1)

K-Number: K252128 · 2025-09-15

Decision Date2025-09-15

Product CodeFRA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Zener® (model ZEN-001-B1) is the device name listed in this FDA 510(k) record. The listed applicant is Uvx, Inc.. It received FDA 510(k) clearance on 2025-09-15 under 510(k) number K252128. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zener® (model ZEN-001-B1)?

Zener® (model ZEN-001-B1) is a medical device that received FDA 510(k) clearance on 2025-09-15. The listed applicant is Uvx, Inc.. The 510(k) number is K252128.

When did Zener® (model ZEN-001-B1) receive FDA 510(k) clearance?

Zener® (model ZEN-001-B1) received FDA 510(k) clearance on 2025-09-15, under 510(k) number K252128.

Who is the listed applicant for Zener® (model ZEN-001-B1)?

The FDA 510(k) record lists Uvx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zener® (model ZEN-001-B1)?

The FDA product code for Zener® (model ZEN-001-B1) is FRA.

Related Devices (Code: FRA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241140ViroZap Indoor Air Purifier, In Duct Model 1008Applied Photonix, LLC K232642AirKEE T900Healkee Medical Pte, Ltd.K232933AirKEE P900Healkee Medical Pte, Ltd.K232645Airgle Room Air PurifierAirgle Corporation K221540Synexis Sphere RxSynexis, LLC K222702RGS; RGS MiniGenesis Air, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.