K202255 is an FDA 510(k) clearance for the Skypro, SP02 Mask (3). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Skypro Medical Supplies Company (Hong Kong, CN). The FDA issued a Cleared decision on December 24, 2021, 501 days after receiving the submission on August 10, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202255 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2020 |
| Decision Date | December 24, 2021 |
| Days to Decision | 501 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |