K220990 is an FDA 510(k) clearance for the Qorda QD1. This device is classified as a Cleaner, Air, Medical Recirculating (Class II - Special Controls, product code FRF).
Submitted by Winix, Inc. (Hwaseong-Si, KR). The FDA issued a Cleared decision on September 14, 2022, 163 days after receiving the submission on April 4, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5045.
| 510(k) Number | K220990 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2022 |
| Decision Date | September 14, 2022 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRF — Cleaner, Air, Medical Recirculating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5045 |