K252908 is an FDA 510(k) clearance for the Easydrip Classic Pen Needle. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Sandstone Medical (Suzhou), Inc. (Suzhou, CN). The FDA issued a Cleared decision on March 25, 2026, 194 days after receiving the submission on September 12, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K252908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2025 |
| Decision Date | March 25, 2026 |
| Days to Decision | 194 days |
| Submission Type | Special |
| 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 |