QNQ · Low Dead Space Piston Syringe
General Hospital · 21 CFR 880.5860 · Class 2
Overview
| Product Code | QNQ |
|---|---|
| Device Name | Low Dead Space Piston Syringe |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252814 | 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 | CMT Health PTE., Ltd. | Feb 19, 2026 | SESE |
| K250127 | TSK Syringe | Tsk Laboratory, Japan | Jul 30, 2025 | SESE |
| K250138 | Small Volume 0.2mL Syringe | Prosum Medical Limited | Apr 2, 2025 | SESE |
| K242291 | 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 | Sol-Millennium Medical, Inc. | Nov 20, 2024 | SESE |
| K232943 | Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe | Smiths Medical Asd, Inc. | May 31, 2024 | SESE |
| K241190 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | Poonglim Pharmatech, Inc. | May 29, 2024 | SESE |
| K231856 | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) | Medexel Co.,Ltd | Mar 15, 2024 | SESE |
| K221860 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | Poonglim Pharmatech, Inc. | Sep 15, 2023 | SESE |
| K213010 | FEELject LDV (Low dead volume) syringe | Feeltech Co., Ltd. | May 31, 2023 | SESE |
| K213013 | Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe | Jeil Tech Co., Ltd. | Sep 19, 2022 | SESE |
| K220083 | LDV((Low Dead Volume )Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | May 25, 2022 | SESE |
| K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe | Poonglim Pharmatech, Inc. | Feb 16, 2021 | SESE |
Top Applicants
- Poonglim Pharmatech, Inc. — 3 clearances
- Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. — 1 clearance
- CMT Health PTE., Ltd. — 1 clearance
- Feeltech Co., Ltd. — 1 clearance
- Jeil Tech Co., Ltd. — 1 clearance
