Atlas FDA

QNQ

12 FDA 510(k) clearances · Product code

194 daysmedian time to decision
445 days90th percentile
12clearances measured

FDA profile

Official device name
Low Dead Space Piston Syringe
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5860
Medical specialty
General Hospital
FDA 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.
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RecordFirmDate
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 (K252814)CMT Health PTE., Ltd.2026-02-19
TSK Syringe (K250127)Tsk Laboratory, Japan2025-07-30
Small Volume 0.2mL Syringe (K250138)Prosum Medical Limited2025-04-02
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 (K242291)Sol-Millennium Medical, Inc.2024-11-20
Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe (K232943)Smiths Medical Asd, Inc.2024-05-31
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe (K241190)Poonglim Pharmatech, Inc.2024-05-29
TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) (K231856)Medexel Co.,Ltd2024-03-15
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe (K221860)Poonglim Pharmatech, Inc.2023-09-15
FEELject LDV (Low dead volume) syringe (K213010)Feeltech Co., Ltd.2023-05-31
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe (K213013)Jeil Tech Co., Ltd.2022-09-19
LDV((Low Dead Volume )Syringe (K220083)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2022-05-25
PLPT LDV (Low Dead Volume) Sterile Syringe (K210443)Poonglim Pharmatech, Inc.2021-02-16

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Every clearance here is in the API, with alerts when new ones post.