Cleared Traditional

Sterile Auto-Disable Syringes with/without Needle for Single Use (K231727) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231727 · Wepon Medical Technology Co., Ltd. · General Hospital
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Sep 2023
Decision
87d
Days
Class 2
Risk

K231727 is an FDA 510(k) clearance for the Sterile Auto-Disable Syringes with/without Needle for Single Use. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Wepon Medical Technology Co., Ltd. (Wenling, CN). The FDA issued a Cleared decision on September 8, 2023 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wepon Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K231727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2023
Decision Date September 08, 2023
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 129d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 239
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K231727.
Disposable Sterile Syringe
K221777 · Weihai Shengjie Medical Technology Co., Ltd. · Oct 2023
VeriSafe Safety sterile syringes
K231792 · Promisemed Hangzhou Meditech Co., Ltd. · Sep 2023
BD Texium™ Needle-Free Syringe
K231888 · Care Fusion · Sep 2023
A-TAP (previously called Arthrotap)
K231900 · Elcam Medical Acal · Jul 2023
Hypodermic Syringes & Needle
K222925 · Lifelong Meditech Private Limited · Jul 2023
Avitus® DragonWing Large Volume Autograft Delivery System
K231456 · Avitus Orthopaedics, Inc. · Jul 2023