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., Feeltech Co., Ltd. and Jeil Tech Co., Ltd..

12
Total
12
Cleared
222d
Avg days
2021
Since
Declining activity - 4 submissions in the last 2 years vs 6 in the prior period
Review times improving: avg 137d recently vs 302d 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 declined in recent years - 4 submissions in the last 24 months compared to 6 in the prior period.

FDA 510(k) Review Time - QNQ Product Code

Recent submissions under QNQ have taken an average of 137 days to reach a decision - down from 302 days historically, suggesting improved FDA processing for this classification.

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