Cleared Traditional

Small Volume 0.2mL Syringe

K250138 · Prosum Medical Limited · General Hospital

Apr 2025

Decision

75d

Days

Class 2

Risk

About This 510(k) Submission

K250138 is an FDA 510(k) clearance for the Small Volume 0.2mL Syringe, 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 review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K250138 FDA.gov
FDA Decision	Cleared 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

Device Classification

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.