Cleared Traditional

Sterile syringes for single use with/without needle (K231729) - FDA 510(k) Clearance

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

K231729 · Wepon Medical Technology Co., Ltd. · General Hospital
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Sep 2023
Decision
87d
Days
Class 2
Risk

K231729 is an FDA 510(k) clearance for the Sterile syringes for single use with/without needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), 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 880.5570 - 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 K231729 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
Combination Product No
PCCP Authorized No
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 FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 Consultant

Shanghai Lingfu Technology Co., Ltd.
Esther Zhang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 196
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K231729.
VitreJect® Needle
K230959 · Ocuject, LLC · Sep 2023
Sterile Hypodermic Needles for Single Use
K231720 · Wepon Medical Technology Co., Ltd. · Sep 2023
Sterile Safety Hypodermic Needles for Single Use
K231723 · Wepon Medical Technology Co., Ltd. · Sep 2023
NovoFine® Plus
K231255 · Novo Nordisk, Inc. · Aug 2023
Altaviz Needle Kit II
K231261 · Altaviz, LLC · Jul 2023
EZ-IO Intraosseous Vascular Access System
K231924 · Teleflex Medical · Jul 2023