QNQ — Low Dead Space Piston Syringe Class II
FDA product code QNQ covers "Low Dead Space Piston Syringe", a Class II medical device regulated under 21 CFR 880.5860. Submissions are reviewed by the General Hospital panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QNQ
- Device Class
- Class II
- Regulation Number
- 880.5860
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252814 | cmt health pte | Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low | February 19, 2026 |
| K250127 | tsk laboratory, japan | TSK Syringe | July 30, 2025 |
| K250138 | prosum medical limited | Small Volume 0.2mL Syringe | April 2, 2025 |
| K242291 | sol-millennium medical | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low | November 20, 2024 |
| K232943 | smiths medical asd | Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe | May 31, 2024 |
| K241190 | poonglim pharmatech | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volum | May 29, 2024 |
| K231856 | medexel co | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) | March 15, 2024 |
| K221860 | poonglim pharmatech | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volum | September 15, 2023 |
| K213010 | feeltech co | FEELject LDV (Low dead volume) syringe | May 31, 2023 |
| K213013 | jeil tech co | Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe | September 19, 2022 |
| K220083 | anhui hongyu wuzhou medical manufacturer co | LDV((Low Dead Volume )Syringe | May 25, 2022 |
| K210443 | poonglim pharmatech | PLPT LDV (Low Dead Volume) Sterile Syringe | February 16, 2021 |