510(k) · Cleared
ClearedAerus Medical Guardian,model F170A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aerus Medical, LLC · FRA Purifier, Air, Ultraviolet, Medical
Cleared on Jun 17, 2020 after a 42-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jun 17, 2020
- Review
- 42 days
- Class
- Class II
- Product code
- FRA
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK201220 Aerus Medical Guardian,model F170AAerus Medical, LLC · 2020
- Descendant · cites it directly · 0 of its ownK221540 Synexis Sphere RxSynexis, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K221540Synexis Sphere RxSynexis, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K201220 | Aerus Medical Guardian,model F170A | Aerus Medical, LLC | 2020 | — |
| +1 | K221540 | Synexis Sphere Rx | Synexis, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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 FRA? 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 FRA device
- #1 K212644 Aura Stormscore 13.9 · 6 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221540 | Synexis Sphere Rx | 2023 | 0 |
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?
- Of its descendants, K221540 (Synexis, LLC, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FRA devicesFRA Purifier, Air, Ultraviolet, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · FRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRA
205in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRA
No recall names FRA since 2007.
Adverse event reports per year · FRA
2in 2024
MAUDE reports naming product code FRA, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 5 | 190 | 0 | 1 |
| 2022 | 4 | 175 | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 4 | 205 | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (145 words)
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
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K201220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201220: Aerus Medical Guardian,model F170A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201220
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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