Cleared Traditional

K230061 - Insulin Syringe (FDA 510(k) Clearance)

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

K230061 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · General Hospital
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Nov 2023
Decision
325d
Days
Class 2
Risk

K230061 is an FDA 510(k) clearance for the Insulin Syringe. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. (Anqing, CN). The FDA issued a Cleared decision on November 30, 2023 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K230061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2023
Decision Date November 30, 2023
Days to Decision 325 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
197d slower than avg
Panel avg: 128d · This submission: 325d
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 Consultant

Shanghai Mind-Link Consulting Co., Ltd.
Evan Hu

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 - FMF Syringe, Piston

All 748
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