QNQ · Class II · 21 CFR 880.5860

FDA Product Code QNQ: Low Dead Space Piston Syringe

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.

Leading manufacturers include Poonglim Pharmatech, Inc., Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. and Medexel Co.,Ltd.

12
Total
12
Cleared
222d
Avg days
2021
Since
Stable submission activity - 6 submissions in the last 2 years
Review times improving: avg 139d recently vs 366d historically

FDA 510(k) Cleared Low Dead Space Piston Syringe Devices (Product Code QNQ)

12 devices
1–12 of 12
Cleared Feb 19, 2026
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe
K252814
CMT Health PTE., Ltd.
General Hospital · 168d
Cleared Jul 30, 2025
TSK Syringe
K250127
Tsk Laboratory, Japan
General Hospital · 194d
Cleared Apr 02, 2025
Small Volume 0.2mL Syringe
K250138
Prosum Medical Limited
General Hospital · 75d
Cleared Nov 20, 2024
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.
General Hospital · 110d
Cleared May 31, 2024
Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe
K232943
Smiths Medical Asd, Inc.
General Hospital · 254d
Cleared May 29, 2024
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe
K241190
Poonglim Pharmatech, Inc.
General Hospital · 30d
Cleared Mar 15, 2024
TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
K231856
Medexel Co.,Ltd
General Hospital · 266d
Cleared Sep 15, 2023
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
K221860
Poonglim Pharmatech, Inc.
General Hospital · 445d
Cleared May 31, 2023
FEELject LDV (Low dead volume) syringe
K213010
Feeltech Co., Ltd.
General Hospital · 618d
Cleared Sep 19, 2022
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
K213013
Jeil Tech Co., Ltd.
General Hospital · 364d
Cleared May 25, 2022
LDV((Low Dead Volume )Syringe
K220083
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
General Hospital · 135d
Cleared Feb 16, 2021
PLPT LDV (Low Dead Volume) Sterile Syringe
K210443
Poonglim Pharmatech, Inc.
General Hospital

About Product Code QNQ - Regulatory Context

510(k) Submission Activity

12 total 510(k) submissions under product code QNQ since 2021, with 12 receiving FDA clearance (average review time: 222 days).

Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.

FDA Review Time

Recent submissions under QNQ have taken an average of 139 days to reach a decision - down from 366 days historically, suggesting improved FDA processing for this classification.

QNQ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →