510(k) · Cleared
ClearedBluezone Model RX-450 Air Purifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bluezone Products, Inc. · FRA Purifier, Air, Ultraviolet, Medical
Cleared on Feb 17, 2022 as substantially equivalent to K062716 (Eco-Rx, Inc., 2006) after a 167-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Feb 17, 2022
- Review
- 167 days
- Class
- Class II
- Product code
- FRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062716 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK062716 Eco-RX Air Purifier with UV Light, Model RX-400Eco-Rx, Inc. · 2006
- This deviceK212824 Bluezone Model RX-450 Air PurifierBluezone Products, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062716 | Eco-RX Air Purifier with UV Light, Model RX-400 | Eco-Rx, Inc. | 2006 | — |
| 0 (this device) | K212824 | Bluezone Model RX-450 Air Purifier | Bluezone Products, Inc. | 2022 | — |
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 |
|---|---|---|---|
| * | K062716 | Eco-RX Air Purifier with UV Light, Model RX-400Summary page 4…V Air Purifier, 21 C.F.R. §880.6500 Class II Product Code: FRA Review Panel General Hospital Predicate Device ECO-Rx Air Purifier with UV Light Model Rx-400 cleared in K062716 Device Description The Bluezone Model RX-450 is an air purification device that uses germicidal UV bulbs to inactivate viral, ba… | 2006 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K062716.
How does its category compare?
All FRA devicesFRA Purifier, Air, Ultraviolet, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The Bluezone Model Rx-450 Air Purifier is a free standing, air purifying device utilizing germicidal ultraviolet light (UV-C wavelengths near 254nm) intended for inactivation of indoor airborne aerosols including bacteria, mold, and virus in medical facilities and occupied spaces.
The Bluezone Model Rx-450 Air Purifier has been demonstrated to entrain and destroy the following exposure/working conditions:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212824 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212824: Bluezone Model RX-450 Air Purifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212824
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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