# K201220: Aerus Medical Guardian,model F170A

- Pathway: 510(k) (Traditional)
- Applicant: Aerus Medical, LLC
- Decided: Jun 17, 2020 after 42 days
- Product code: FRA (Purifier, Air, Ultraviolet, Medical)
- Device class: 2
- Regulation: 21 CFR 880.6500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K221540: Synexis Sphere Rx (2023), 0 descendants of its own

## Indications for use
The Aerus Medical Guardian, model F170A is a device intended for medical purposes that is used for the reduction of staphylococcus epidermidis and erwinia herbicola bacteria, MS2 and Phi-X174 viruses and aspergillus niger fungal spores and bacillus globigii bacterial spores from the air in a temperature-controlled professional healthcare environment of 70~71°F, 40~45% RH. The Aerus Medical Guardian, model F170A demonstrated the reduction of staphylococcus epidermidis and erwinia herbicola bacteria, MS2 and Phi-X174 viruses and aspergillus niger fungal spores and bacillus globigii bacterial spores under the following conditions. Organism Type Organism Name Test Temp/RH Exposure Time (m) Avg Log-Reduction Bacteria Staphylococcus epidermidis 72°F / 50% 60 5.95 Bacteria Erwinia herbicola 72°F / 50% 60 5.12 Virus MS2 72°F / 50% 60 5.58 Virus Phi-X174 72°F / 50% 60 4.19 Fungal Spore Aspergillus niger 72°F / 50% 60 4.12 Bacterial Spore Bacillus globigii 72°F /50% 60 4.22

Source page: https://510kreport.com/device/K201220
Methodology: https://510kreport.com/methodology