510(k) · Cleared
ClearedEOS Air Cleaner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Ajax Medical Equipment Co., Ltd. · FRA Purifier, Air, Ultraviolet, Medical
Cleared on Jun 11, 2021 as substantially equivalent to K200500 (Molekule, Inc., 2020) after a 263-day review. Its family tree reaches back 5 generations to 2003.
- Decided
- Jun 11, 2021
- Review
- 263 days
- Class
- Class II
- Product code
- FRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K023830 (2003). No later device cites it as a predicate yet.
- Root · 5 generations backK023830 Airocide TI02Kes Science & Technology, Inc. · 2003
- 4 generations backK033448 Electro-Optical Air Sterilizer with IonizerJohn Mfg., Ltd. · 2004
- 3 generations backK052732 Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model…Abracair, Inc. · 2006
- 2 generations backK161468 Transformair Indoor Air PurifierTransformair, LLC · 2017
- 1 generation backK200500 Molekule Air Pro RXMolekule, Inc. · 2020
- This deviceK202766 EOS Air CleanerGuangzhou Ajax Medical Equipment Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K023830 | Airocide TI02 | Kes Science & Technology, Inc. | 2003 | — |
| −4 | K033448 | Electro-Optical Air Sterilizer with Ionizer | John Mfg., Ltd. | 2004 | — |
| −3 | K052732 | Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30P | Abracair, Inc. | 2006 | — |
| −2 | K161468 | Transformair Indoor Air Purifier | Transformair, LLC | 2017 | — |
| −1 | K200500 | Molekule Air Pro RX | Molekule, Inc. | 2020 | — |
| 0 (this device) | K202766 | EOS Air Cleaner | Guangzhou Ajax Medical Equipment Co., Ltd. | 2021 | — |
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 |
|---|---|---|---|
| * | K200500 | Molekule Air Pro RXSummary page 4…umber: 21 CFR 880.6500 ♦ Regulation Class: II 3. Date Prepared: June 9, 2021 4. Predicate Device ♦ 510(k) number: K200500 ♦ Sponsor: Molekule, Inc. ♦ Regulation Name: Medical Ultraviolet Air Purifier ♦ Trade Name… | 2020 |
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 18 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K200500.
How does its category compare?
All FRA devicesFRA Purifier, Air, Ultraviolet, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
EOS Air Cleaner is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation in general medical environment.
The core technology components of the EOS Air Cleaner have been demonstrated to destroy MS2 bacteriophage bioaerosol entrained on the filter to achieve an average 4 log reduction over 4 hours in a 30 cubic meter chamber.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202766: EOS Air Cleaner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202766
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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