# K252128: Zener® (model ZEN-001-B1)

- Pathway: 510(k) (Traditional)
- Applicant: Uvx, Inc.
- Decided: Sep 15, 2025 after 70 days
- Product code: FRA (Purifier, Air, Ultraviolet, Medical)
- Device class: 2
- Regulation: 21 CFR 880.6500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951981 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133800: Odorox (R) Idu/RX (TM) in-Duct Models, Odorox (R) Idu/RX (TM) Mobile Disinfection Units, Odorox (R) Slimline/RX (TM) Slimli, Hgi Industires (2014) Summary page 5.

## Indications for use
Zener® (model ZEN-001-B1) is an ultraviolet (UV) air purifying device intended for the reduction of bacteria in air in medical facilities. Zener 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). Zener is non sterile.

Source page: https://510kreport.com/device/K252128
Methodology: https://510kreport.com/methodology