# K222416: RIA Safeguard

- Pathway: 510(k) (Traditional)
- Applicant: Ria Tech Co., Ltd.
- Decided: May 1, 2023 after 264 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
Longest line of descent: 1 generation back to K112728 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112728: Hepairx Ventilating Air Purifier, Air Innovations, Inc. (2013) Summary page 4.

## Indications for use
The RIA SafeGuard is intended as a room recirculating air cleaner. The system is used for filtering out airborne particles PM2.5 from the air for medical purposes, and is intended for over-the-counter use. The RIA SafeGuard has wind speed of 1.3 m/s and airflow of 135 CMH (m3/h). Using the HEPA H13 filter, it provides a 4 log (99.99%) reduction in suspended particulate PM2.5 in 120 minutes within a 29.75 m3 room.

Source page: https://510kreport.com/device/K222416
Methodology: https://510kreport.com/methodology