# K220990: Qorda QD1

- Pathway: 510(k) (Traditional)
- Applicant: Winix, Inc.
- Decided: Sep 14, 2022 after 163 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
Longest line of descent: 3 generations back to K972064 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200321: Novaerus NV1050, Novaerus Us, Inc. (2020) Summary page 4.

## Indications for use
The Qorda QD1 is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes. The Qorda QD1 has been demonstrated to remove the following organisms under the following exposure conditions: MS2 bacteriophage: Turbo MODE, 5.6 log reduction, 20 minutes; Sleep MODE, 4.9 log reduction, 45 minutes. Bacillus subtilis endospores: Turbo MODE, 4.4 log reduction, 20 minutes; Sleep MODE, 4.3 log reduction, 60 minutes.

Source page: https://510kreport.com/device/K220990
Methodology: https://510kreport.com/methodology