K251375 is an FDA 510(k) clearance for the PuraCath Firefly Needleless Connector IT (9005). This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Puracath Medical, Inc. (Newark, US). The FDA issued a Cleared decision on February 12, 2026, 286 days after receiving the submission on May 2, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K251375 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2025 |
| Decision Date | February 12, 2026 |
| Days to Decision | 286 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA - Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |