K222141 is an FDA 510(k) clearance for the Safety Blood Collection Needle (Without Needle Holder). 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. (Anqing City, CN). The FDA issued a Cleared decision on October 21, 2022, 93 days after receiving the submission on July 20, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K222141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 2022 |
| Decision Date | October 21, 2022 |
| Days to Decision | 93 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 |