K250138 is an FDA 510(k) clearance for the Small Volume 0.2mL Syringe. This device is classified as a Low Dead Space Piston Syringe (Class II - Special Controls, product code QNQ).
Submitted by Prosum Medical Limited (Uxbridge, GB). The FDA issued a Cleared decision on April 2, 2025, 75 days after receiving the submission on January 17, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860. A Low Dead Space Syringe Is A Piston Syringe Designed To Reduce Medication Waste. The Device Consists Of A Calibrated Hollow Barrel, A Moveable Plunger, And May Include A Needle. The Device Can Be Used By Health Care Professions Or For Self-injection By The Patient..
| 510(k) Number | K250138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2025 |
| Decision Date | April 02, 2025 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | QNQ - Low Dead Space Piston Syringe |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
| Definition | A Low Dead Space Syringe Is A Piston Syringe Designed To Reduce Medication Waste. The Device Consists Of A Calibrated Hollow Barrel, A Moveable Plunger, And May Include A Needle. The Device Can Be Used By Health Care Professions Or For Self-injection By The Patient. |