K213183 is an FDA 510(k) clearance for the Safety Insulin Pen Needles. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Zhejiang Kindly Medical Devices Co., Ltd. (Wenzhou, CN). The FDA issued a Cleared decision on October 14, 2022, 380 days after receiving the submission on September 29, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K213183 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2021 |
| Decision Date | October 14, 2022 |
| Days to Decision | 380 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 |