510(k) · Cleared
ClearedRIA Safeguard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ria Tech Co., Ltd. · FRF Cleaner, Air, Medical Recirculating
Cleared on May 1, 2023 as substantially equivalent to K112728 (Air Innovations, Inc., 2013) after a 264-day review. Its family tree reaches back 1 generation to 2013.
- Decided
- May 1, 2023
- Review
- 264 days
- Class
- Class II
- Product code
- FRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K112728 (2013). No later device cites it as a predicate yet.
- Root · 1 generation backK112728 Hepairx Ventilating Air PurifierAir Innovations, Inc. · 2013
- This deviceK222416 RIA SafeguardRia Tech Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K112728 | Hepairx Ventilating Air Purifier | Air Innovations, Inc. | 2013 | — |
| 0 (this device) | K222416 | RIA Safeguard | Ria Tech Co., Ltd. | 2023 | — |
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 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? (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 |
|---|---|---|---|
| * | K112728 | Hepairx Ventilating Air PurifierSummary page 4…, Inc. Classification Product Code: FRF Regulation number: 880.5045 Device Class: Ⅱ 510(k) Number: K112728 4. Identification of the Reference Device Predicate Device Name: Novaerus NV1050 Manufacturer:… | 2013 |
| † | K200321 | Novaerus NV1050 | 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?
- Its one ancestor has no 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. 2023, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222416: RIA Safeguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222416
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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