K214075 is an FDA 510(k) clearance for the Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder). This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. (Anqing, CN). The FDA issued a Cleared decision on April 12, 2022, 106 days after receiving the submission on December 27, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K214075 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2021 |
| Decision Date | April 12, 2022 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI - Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |