510(k) · Cleared
ClearedEco-RX Air Purifier with UV Light, Model RX-400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eco-Rx, Inc. · FRA Purifier, Air, Ultraviolet, Medical
Cleared on Oct 27, 2006 after a 45-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Oct 27, 2006
- Review
- 45 days
- Class
- Class II
- Product code
- FRA
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK062716 Eco-RX Air Purifier with UV Light, Model RX-400Eco-Rx, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK133800 Odorox (R) Idu/RX (TM) in-Duct Models, Odorox (R) Idu/RX (TM) Mobile…Hgi Industires · 2014
- Descendant · 2 generations on · 0 of its ownK252128 Zener® (model ZEN-001-B1)Uvx, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK212824 Bluezone Model RX-450 Air PurifierBluezone Products, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See all- K133800Odorox (R) Idu/RX (TM) in-Duct Models, Odorox (R) Idu/RX (TM) Mobile Disinfection Units…Hgi Industires · 2014 · cites it directly1descendant
- K252128Zener® (model ZEN-001-B1)Uvx, Inc. · 2025 · 2 generations on0descendants
- K212824Bluezone Model RX-450 Air PurifierBluezone Products, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062716 | Eco-RX Air Purifier with UV Light, Model RX-400 | Eco-Rx, Inc. | 2006 | — |
| +1 | K133800 | Odorox (R) Idu/RX (TM) in-Duct Models, Odorox (R) Idu/RX (TM) Mobile… | Hgi Industires | 2014 | — |
| +2 | K252128 | Zener® (model ZEN-001-B1) | Uvx, Inc. | 2025 | — |
| +1 | K212824 | Bluezone Model RX-450 Air Purifier | Bluezone Products, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K133800 (Hgi Industires, 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FRA devicesFRA Purifier, Air, Ultraviolet, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The ECO-Rx Air Purifier with UV Light, Model Rx-400 is a flow-through indoor air-purification system for the inactivation of indoor airborne bacteria.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K062716 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062716: Eco-RX Air Purifier with UV Light, Model RX-400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062716
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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