Cleared Traditional

K232943 - Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe

K232943 is an FDA 510(k) clearance for Hypodermic Needle-Pro EDGE Safety Devic..., manufactured by Smiths Medical Asd, Inc.. The device is a Class 2 General Hospital device with product code QNQ cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K232943 · Smiths Medical Asd, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
254d
Days
Class 2
Risk

K232943 is an FDA 510(k) clearance for the Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe. Classified as Low Dead Space Piston Syringe (product code QNQ), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (Plymouth, US). The FDA issued a Cleared decision on May 31, 2024 after a review of 254 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Smiths Medical Asd, Inc. devices

FDA 510(k) Submission Details - K232943

510(k) Number K232943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2023
Decision Date May 31, 2024
Days to Decision 254 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 129d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QNQ Device Classification - Class 2, Special Controls

Product Code QNQ Low Dead Space Piston Syringe
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - QNQ Low Dead Space Piston Syringe

All 11
Devices cleared under the same product code (QNQ) and FDA review panel - the closest regulatory comparables to K232943.
TSK Syringe
K250127 · Tsk Laboratory, Japan · Jul 2025
Small Volume 0.2mL Syringe
K250138 · Prosum Medical Limited · Apr 2025
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. · Nov 2024
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe
K241190 · Poonglim Pharmatech, Inc. · May 2024
TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
K231856 · Medexel Co.,Ltd · Mar 2024
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
K221860 · Poonglim Pharmatech, Inc. · Sep 2023