Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
FDA 510(k) K213013 · Jeil Tech Co., Ltd.
510(k) numberK213013
Submission
- Device name
- Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
- Applicant
- Jeil Tech Co., Ltd.
Sejong-Si, KR - Received
- September 20, 2021
- Decision date
- September 19, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QNQ – Low Dead Space Piston Syringe
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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.
Other 510(k)s with product code QNQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252814 | Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead…QNQ · Traditional | CMT Health PTE., Ltd. | 02/19/2026SE |
| K250127 | TSK SyringeQNQ · Traditional | Tsk Laboratory, Japan | 07/30/2025SE |
| K250138 | Small Volume 0.2mL SyringeQNQ · Traditional | Prosum Medical Limited | 04/02/2025SE |
| K242291 | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead…QNQ · Traditional | Sol-Millennium Medical, Inc. | 11/20/2024SE |
| K232943 | Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space SyringeQNQ · Traditional | Smiths Medical Asd, Inc. | 05/31/2024SE |
| K241190 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume)…QNQ · Special | Poonglim Pharmatech, Inc. | 05/29/2024SE |
| K231856 | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))QNQ · Traditional | Medexel Co.,Ltd | 03/15/2024SE |
| K221860 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume)…QNQ · Traditional | Poonglim Pharmatech, Inc. | 09/15/2023SE |
| K213010 | FEELject LDV (Low dead volume) syringeQNQ · Traditional | Feeltech Co., Ltd. | 05/31/2023SE |
| K220083 | LDV((Low Dead Volume )SyringeQNQ · Traditional | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 05/25/2022SE |
Questions and answers
When was Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe cleared by the FDA?
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe (K213013) received a 510(k) decision of Substantially Equivalent on September 19, 2022, 364 days after the submission was received.
What is the product code of K213013?
The FDA product code is QNQ – Low Dead Space Piston Syringe, a Class II (moderate risk) device regulated under 21 CFR 880.5860.