Cleared Traditional

K252128 - Zener® (model ZEN-001-B1) (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252128 · Uvx, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Sep 2025
Decision
70d
Days
Class 2
Risk

K252128 is an FDA 510(k) clearance for the Zener® (model ZEN-001-B1). Classified as Purifier, Air, Ultraviolet, Medical (product code FRA), Class II - Special Controls.

Submitted by Uvx, Inc. (Vancouver, CA). The FDA issued a Cleared decision on September 15, 2025 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6500 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Uvx, Inc. devices

Submission Details

510(k) Number K252128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 128d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code FRA Purifier, Air, Ultraviolet, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Third Party Review Group, LLC
Dave Yungvirt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRA Purifier, Air, Ultraviolet, Medical

All 35
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