K252398 is an FDA 510(k) clearance for the SURFLO Hybria Closed System Safety IV Catheter. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Terumo Medical Products Hangzhou Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on December 17, 2025, 139 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.
| 510(k) Number | K252398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2025 |
| Decision Date | December 17, 2025 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOZ - Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |