Cleared Traditional

K252814 - Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe (FDA 510(k) Clearance)

Also includes:
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

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252814 · CMT Health PTE., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
168d
Days
Class 2
Risk

K252814 is an FDA 510(k) clearance for the Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe. Classified as Low Dead Space Piston Syringe (product code QNQ), Class II - Special Controls.

Submitted by CMT Health PTE., Ltd. (Singapore, SG). The FDA issued a Cleared decision on February 19, 2026 after a review of 168 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all CMT Health PTE., Ltd. devices

Submission Details

510(k) Number K252814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 128d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QNQ Low Dead Space Piston Syringe
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - QNQ Low Dead Space Piston Syringe

All 11
Devices cleared under the same product code (QNQ) and FDA review panel - the closest regulatory comparables to K252814.
TSK Syringe
K250127 · Tsk Laboratory, Japan · Jul 2025
Small Volume 0.2mL Syringe
K250138 · Prosum Medical Limited · Apr 2025
SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle
K242291 · Sol-Millennium Medical, Inc. · Nov 2024
Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe
K232943 · Smiths Medical Asd, Inc. · May 2024
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe
K241190 · Poonglim Pharmatech, Inc. · May 2024
TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
K231856 · Medexel Co.,Ltd · Mar 2024