Submission Details
| 510(k) Number | K250724 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 10, 2025 |
| Decision Date | July 30, 2025 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Intraosseous Infusion Needles
Jul 2025
Decision
142d
Days
Class 2
Risk
About This 510(k) Submission
K250724 is an FDA 510(k) clearance for the Intraosseous Infusion Needles, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Spectrum Vascular (White Plains, US). The FDA issued a Cleared decision on July 30, 2025, 142 days after receiving the submission on March 10, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.
Device Classification
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
Manufacturer
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