Cleared Traditional

Profoject? Low Dead Space Syringe /Profoject? Tuberculin Syringe; Profoject? Low Dead Space Syringe with Needle /Profoject? Tuberculin Syringe with Needle; Profoject? Low Dead Space Syringe with Permanent Needle /Profoject? Tuberculin Syringe with Permanent Needle; Profoject? Low Dead Space Safety Syringe /Profoject? Tuberculin Safety Syringe

K252814 · CMT Health PTE., Ltd. · General Hospital

Feb 2026

Decision

168d

Days

Class 2

Risk

About This 510(k) Submission

K252814 is an FDA 510(k) clearance for the Profoject? Low Dead Space Syringe /Profoject? Tuberculin Syringe; Profoject? Low Dead Space Syringe with Needle /Profoject? Tuberculin Syringe with Needle; Profoject? Low Dead Space Syringe with Permanent Needle /Profoject? Tuberculin Syringe with Permanent Needle; Profoject? Low Dead Space Safety Syringe /Profoject? Tuberculin Safety Syringe, a Low Dead Space Piston Syringe (Class II — Special Controls, product code QNQ), submitted by CMT Health PTE., Ltd. (Singapore, SG). The FDA issued a Cleared decision on February 19, 2026, 168 days after receiving the submission on September 4, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K252814 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 04, 2025
Decision Date	February 19, 2026
Days to Decision	168 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.