K202319 is an FDA 510(k) clearance for the Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type). This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Tianjin Huahong Technology Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on November 12, 2021, 452 days after receiving the submission on August 17, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K202319 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2020 |
| Decision Date | November 12, 2021 |
| Days to Decision | 452 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 |