Cleared Traditional

Insulin Pen Needle (K230043) - FDA 510(k) Clearance

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

K230043 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · General Hospital
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Sep 2023
Decision
257d
Days
Class 2
Risk

K230043 is an FDA 510(k) clearance for the Insulin Pen Needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. (Anqing, CN). The FDA issued a Cleared decision on September 20, 2023 after a review of 257 days - an extended review 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: 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 Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. devices

Submission Details

510(k) Number K230043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2023
Decision Date September 20, 2023
Days to Decision 257 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
128d slower than avg
Panel avg: 129d · This submission: 257d
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 Peers - FMI Needle, Hypodermic, Single Lumen

All 199
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K230043.
Sterile Hypodermic Needles for Single Use
K233037 · Zhejiang Kindly Medical Device Co., Ltd. · Dec 2023
SteriCap Safety Needle
K233343 · Ocuject, LLC · Nov 2023
MESORAM® Hypodermic Needle (710301)
K230070 · Promamedical, Inc. · Oct 2023
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