510(k) · Cleared
ClearedZener® (model ZEN-001-B1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uvx, Inc. · FRA Purifier, Air, Ultraviolet, Medical
Cleared on Sep 15, 2025 as substantially equivalent to K133800 (Hgi Industires, 2014) after a 70-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Sep 15, 2025
- Review
- 70 days
- Class
- Class II
- Product code
- FRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K951981 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951981 | RXAIR 3000 | Clean Air Research & Development | 1995 | — |
| −1 | K133800 | Odorox (R) Idu/RX (TM) in-Duct Models, Odorox (R) Idu/RX (TM) Mobile… | Hgi Industires | 2014 | — |
| 0 (this device) | K252128 | Zener® (model ZEN-001-B1) | Uvx, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRA device
- #1 K212644 Aura Stormscore 13.9 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133800 | Odorox (R) Idu/RX (TM) in-Duct Models, Odorox (R) Idu/RX (TM) Mobile Disinfection Units…Summary page 5… FRA Device Class: Class II Classification Panel: General Hospital 3. Predicate Device(s) Predicate Device 510(k) Number: K133800 Device Name: Odorox® MDU/Rx™ Manufacturer: HGI Industries, Boyton Beach, FL, USA Reference Device 510(k) Number:… | 2014 |
| † | K211194 | Molekule Air Pro | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 19.2 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All FRA devicesFRA Purifier, Air, Ultraviolet, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRA
205in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRA
No recall names FRA since 2007.
Adverse event reports per year · FRA
2in 2024
MAUDE reports naming product code FRA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 5 | 190 | 0 | 1 |
| 2022 | 4 | 175 | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 4 | 205 | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252128: Zener® (model ZEN-001-B1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252128
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026