K212514 is an FDA 510(k) clearance for the Safety Pen Needle for Single Use, Insulin Pen Needles. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Berpu Medical Technology Co., Ltd. (Wenzhou, CN). The FDA issued a Cleared decision on April 29, 2022, 262 days after receiving the submission on August 10, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K212514 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2021 |
| Decision Date | April 29, 2022 |
| Days to Decision | 262 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 |