Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5860](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5860) → QNQ — Low Dead Space Piston Syringe # QNQ · Low Dead Space Piston Syringe _General Hospital · 21 CFR 880.5860 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QNQ ## Overview - **Product Code:** QNQ - **Device Name:** Low Dead Space Piston Syringe - **Regulation:** [21 CFR 880.5860](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5860) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) ## 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QNQ/K252814.md) | 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QNQ/K250127.md) | TSK Syringe | Tsk Laboratory, Japan | Jul 30, 2025 | SESE | | [K250138](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QNQ/K250138.md) | Small Volume 0.2mL Syringe | Prosum Medical Limited | Apr 2, 2025 | SESE | | [K242291](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QNQ/K242291.md) | 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QNQ/K232943.md) | Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe | Smiths Medical Asd, Inc. | May 31, 2024 | SESE | | [K241190](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QNQ/K241190.md) | 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QNQ/K231856.md) | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) | Medexel Co.,Ltd | Mar 15, 2024 | SESE | | [K221860](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QNQ/K221860.md) | 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QNQ/K213010.md) | FEELject LDV (Low dead volume) syringe | Feeltech Co., Ltd. | May 31, 2023 | SESE | | [K213013](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QNQ/K213013.md) | Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe | Jeil Tech Co., Ltd. | Sep 19, 2022 | SESE | | [K220083](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QNQ/K220083.md) | LDV((Low Dead Volume )Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | May 25, 2022 | SESE | | [K210443](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QNQ/K210443.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QNQ](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QNQ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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