Cleared Traditional

Sterile Hypodermic Needles for Single Use (K233037) - FDA 510(k) Clearance

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

K233037 · Zhejiang Kindly Medical Device Co., Ltd. · General Hospital
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Dec 2023
Decision
78d
Days
Class 2
Risk

K233037 is an FDA 510(k) clearance for the Sterile Hypodermic Needles for Single Use. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Zhejiang Kindly Medical Device Co., Ltd. (Wenzhou City, CN). The FDA issued a Cleared decision on December 12, 2023 after a review of 78 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 Zhejiang Kindly Medical Device Co., Ltd. devices

Submission Details

510(k) Number K233037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2023
Decision Date December 12, 2023
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
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 Mind-Link Business Consulting Co., Ltd.
Amy Li

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 199
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K233037.
Verifine® Pen Needles
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Sterile Safety Hypodermic Needles for Single Use
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K233343 · Ocuject, LLC · Nov 2023
MESORAM® Hypodermic Needle (710301)
K230070 · Promamedical, Inc. · Oct 2023
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K230043 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Sep 2023