Cleared Traditional

Safety Insulin Pen Needles (K213183) - FDA 510(k) Clearance

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

K213183 · Zhejiang Kindly Medical Devices Co., Ltd. · General Hospital
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Oct 2022
Decision
380d
Days
Class 2
Risk

K213183 is an FDA 510(k) clearance for the Safety Insulin Pen Needles. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Zhejiang Kindly Medical Devices Co., Ltd. (Wenzhou, CN). The FDA issued a Cleared decision on October 14, 2022 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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. 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 Zhejiang Kindly Medical Devices Co., Ltd. devices

Submission Details

510(k) Number K213183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2021
Decision Date October 14, 2022
Days to Decision 380 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
251d slower than avg
Panel avg: 129d · This submission: 380d
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.
Alice Huang

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 K213183.
Disposable Insulin Pen Needle
K221178 · Ningbo Medsun Medical Co., Ltd. · Nov 2022
Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle
K222124 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Nov 2022
IO Needle Safety Sheath
K220890 · Actuated Medical, Inc. · Oct 2022
Sterile Hypodermic Needles for Single Use
K221066 · Sichuan Prius Biotechnology Co., Ltd. · Oct 2022
Sterile Safety Hypodermic Needles for Single Use
K221080 · Sichuan Prius Biotechnology Co., Ltd. · Oct 2022
Promisemed X-Safety Pen Needle
K220129 · Promisemed Hangzhou Meditech Co., Ltd. · Sep 2022