# K203189: Aerocure-MD

- Pathway: 510(k) (Traditional)
- Applicant: Aerobiotix, Inc.
- Decided: Jan 21, 2021 after 86 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: 1 generation back to K972064 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972064: Microcon 800MUV, Microcon 400MUV, Microcon Exc-Buv, Biological Controls, Inc. (1997) Summary page 4.
- K974682: Microcon 800M, Microcon 400M, Microcon Exc, Microcon EX, Microcon Wallmap, Biological Controls, Inc. (1998) Summary page 5.

## Indications for use
The Aerobiotix AEROCURE-MD air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation. In addition, the device removes particles from the air via HEPA filtration.

Source page: https://510kreport.com/device/K203189
Methodology: https://510kreport.com/methodology