# K223835: MA-40, MA-112

- Pathway: 510(k) (Traditional)
- Applicant: Medify Air, LLC
- Decided: Sep 18, 2023 after 270 days
- Product code: FRF (Cleaner, Air, Medical Recirculating)
- Device class: 2
- Regulation: 21 CFR 880.5045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The MA-40 and MA-112 are intended for use as room recirculating air cleaner. The systems are used for filtering out and inactivating airborne particles from the air for medical purposes. The MA-40 has been demonstrated to reduce the following airborne microorganisms by >99.99% in a test chamber of 83ft3 (580 ft3) The MA-112 has been demonstrated to reduce the following airborne microorganisms by >99.99% in a test chamber of 83ft3 (580 ft3)

Source page: https://510kreport.com/device/K223835
Methodology: https://510kreport.com/methodology