Cleared Traditional

K153706 - Insulin Pen Needle

K153706 is an FDA 510(k) clearance for Insulin Pen Needle, manufactured by SteriLance Medical (Suzhou), Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K153706 · SteriLance Medical (Suzhou), Inc. · General Hospital
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Aug 2016
Decision
250d
Days
Class 2
Risk

K153706 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 SteriLance Medical (Suzhou), Inc. (Suzhou, CN). The FDA issued a Cleared decision on August 29, 2016 after a review of 250 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 SteriLance Medical (Suzhou), Inc. devices

FDA 510(k) Submission Details - K153706

510(k) Number K153706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2015
Decision Date August 29, 2016
Days to Decision 250 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
121d slower than avg
Panel avg: 129d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

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

Shenzhen Joyantech Consulting Co., Ltd.
Field Fu

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 534
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K153706.
Advocate Insulin Pen Needles
K160199 · Diabetic Supply of Suncoast, Inc. · Oct 2016
CPL Insulin Pen Needle
K151090 · Cpl Co., Ltd. · Sep 2016
CareSens Pen Needle, Softip Pen Needle
K160575 · Yidobio, Inc. · Sep 2016
Cook Intraosseous Infusion Needles
K160887 · Cook Incorporated · Jul 2016
JSM Insulin Pen Needle
K152166 · Jeesung Medical Co., Ltd. · Jul 2016
BD SafeAssist
K161553 · Becton, Dickinson and Company · Jul 2016