# K221540: Synexis Sphere Rx

- Pathway: 510(k) (Traditional)
- Applicant: Synexis, LLC
- Decided: Jun 14, 2023 after 383 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
Longest line of descent: 7 generations back to K023830 (2003). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211194: Molekule Air Pro, Molekule, Inc. (2021) Summary page 4.
- K201220: Aerus Medical Guardian,model F170A, Aerus Medical, LLC (2020) Summary page 4.

## Indications for use
The Synexis Sphere Rx is a stand-alone air purifier device intended for medical purposes and is used for the reduction of bacteria and viruses in the air. The device is intended for use in professional healthcare environments. The Sphere Rx is not intended for use near HF surgical equipment or MRI settings. The Synexis Sphere Rx air purifier demonstrated a ≥ 4 log reduction of bacteria and viruses under the following exposure/working conditions: Organism Type Organism Name Test Temp/RH Avg Net Log Reduction/Time@ High Fan Speed Gram- bacteria K. aerogenes 25±3 deg C, 60 ±5% RH 4.25 / 240m Gram+ bacteria S. epidermidis 25±3 deg C, 60 ±5% RH 4.19 / 360m Virus MS2 25±3 deg C, 60 ±5% RH 4.55 / 300m Organism Type Organism Name Test Temp/RH Avg Net Log Reduction/Time@ Low Fan Speed Gram- bacteria K. aerogenes 25±3 deg C, 60 ±5% RH 4.25 / 240m Gram+ bacteria S. epidermidis 25±3 deg C, 60 ±5% RH 4.13 / 480m Virus MS2 25±3 deg C, 60 ±5% RH 4.11 / 480m

Source page: https://510kreport.com/device/K221540
Methodology: https://510kreport.com/methodology