K252402 is an FDA 510(k) clearance for the Midline Catheter. This device is classified as a Midline Catheter (Class II - Special Controls, product code PND).
Submitted by Terumo Medical Products Hangzhou Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on December 18, 2025, 140 days after receiving the submission on July 31, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200. The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications For Less Than 28 Days..
| 510(k) Number | K252402 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2025 |
| Decision Date | December 18, 2025 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PND - Midline Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |
| Definition | The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications For Less Than 28 Days. |