Low Dead Space Piston Syringe
The Low Dead Space Piston Syringe is a medical device designed to reduce medication waste by minimizing the residual volume remaining in the syringe after injection, consisting of a calibrated hollow barrel, a moveable plunger, and optionally a needle. It may be used by healthcare professionals or for patient self-injection. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 880.5860 in the General Hospital specialty. It carries product code QNQ and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QNQ
- Device Class
- FDA class 2
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| 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 | Feb 19, 2026 | Substantially Equivalent | CMT Health PTE., Ltd. |
| K250127 | TSK Syringe | Jul 30, 2025 | Substantially Equivalent | Tsk Laboratory, Japan |
| K250138 | Small Volume 0.2mL Syringe | Apr 02, 2025 | Substantially Equivalent | Prosum Medical Limited |
| 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 | Nov 20, 2024 | Substantially Equivalent | Sol-Millennium Medical, Inc. |
| K232943 | Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe | May 31, 2024 | Substantially Equivalent | Smiths Medical Asd, Inc. |
| K241190 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | May 29, 2024 | Substantially Equivalent | Poonglim Pharmatech, Inc. |
| K231856 | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) | Mar 15, 2024 | Substantially Equivalent | Medexel Co.,Ltd |
| K221860 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | Sep 15, 2023 | Substantially Equivalent | Poonglim Pharmatech, Inc. |
| K213010 | FEELject LDV (Low dead volume) syringe | May 31, 2023 | Substantially Equivalent | Feeltech Co., Ltd. |
| K213013 | Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe | Sep 19, 2022 | Substantially Equivalent | Jeil Tech Co., Ltd. |
| K220083 | LDV((Low Dead Volume )Syringe | May 25, 2022 | Substantially Equivalent | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
| K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe | Feb 16, 2021 | Substantially Equivalent | Poonglim Pharmatech, Inc. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.