K181069 is an FDA 510(k) clearance for the Disposable Insulin Pen Needle. 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 August 28, 2018, 127 days after receiving the submission on April 23, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K181069 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2018 |
| Decision Date | August 28, 2018 |
| Days to Decision | 127 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 |