510(k) · Cleared
ClearedBiomoneta Avata Rx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomoneta Research Private Limited · FRF Cleaner, Air, Medical Recirculating
Cleared on Nov 14, 2025 after a 149-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 14, 2025
- Review
- 149 days
- Class
- Class II
- Product code
- FRF
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 FRF? 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 FRF device
- #1 K200321 Novaerus NV1050score 9.9 · 2 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?
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.
How does its category compare?
All FRF devicesFRF Cleaner, Air, Medical Recirculating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FRF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRF
163in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRF
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRF
3in 2013
MAUDE reports naming product code FRF, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 3 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 3 | 163 | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Biomoneta Avata Rx is an over-the-counter (OTC) medical recirculating air cleaner intended to remove particles for medical purposes. The device is intended for indoor use only.
The Biomoneta Avata Rx has been demonstrated to reduce Staphylococcus epidermidis, Klebsiella aerogenes, and MS2 bacteriophage by > 5 log when operated at its highest fan speed for 60 minutes.
Note: The designation “Rx” in the product name is part of the trade name and does not indicate prescription status.
Performance was validated in controlled test chambers measuring 9.1 ft × 9.1 ft × 7 ft (bioaerosol) and 12 ft × 12.5 ft × 15 ft (particle reduction).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K251872 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251872: Biomoneta Avata Rx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251872
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026