K202188 is an FDA 510(k) clearance for the Safety Blood Collection Sets for Single Use. This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. (Taihu, Anqing City, CN). The FDA issued a Cleared decision on February 19, 2021, 199 days after receiving the submission on August 4, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K202188 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2020 |
| Decision Date | February 19, 2021 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | JKA - Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |