# K251872: Biomoneta Avata Rx

- Pathway: 510(k) (Traditional)
- Applicant: Biomoneta Research Private Limited
- Decided: Nov 14, 2025 after 149 days
- Product code: FRF (Cleaner, Air, Medical Recirculating)
- Device class: 2
- Regulation: 21 CFR 880.5045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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).

Source page: https://510kreport.com/device/K251872
Methodology: https://510kreport.com/methodology