Cleared Traditional

K152166 - JSM Insulin Pen Needle

K152166 is an FDA 510(k) clearance for JSM Insulin Pen Needle, manufactured by Jeesung Medical Co., Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K152166 · Jeesung Medical Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
342d
Days
Class 2
Risk

K152166 is an FDA 510(k) clearance for the JSM Insulin Pen Needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Jeesung Medical Co., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on July 11, 2016 after a review of 342 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 Jeesung Medical Co., Ltd. devices

FDA 510(k) Submission Details - K152166

510(k) Number K152166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2015
Decision Date July 11, 2016
Days to Decision 342 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
213d slower than avg
Panel avg: 129d · This submission: 342d
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 Peers - FMI Needle, Hypodermic, Single Lumen

All 272
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K152166.
Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
K161950 · Promisemed Hangzhou Meditech Co., Ltd. · May 2017
BD Pen Needle
K162516 · Becton, Dickinson and Company · Dec 2016
Cook Intraosseous Infusion Needles
K160887 · Cook Incorporated · Jul 2016
BD SafeAssist
K161553 · Becton, Dickinson and Company · Jul 2016
BD Eclipse Hypodermic Needle
K161170 · Becton, Dickinson and Company · May 2016
K-Pack II Needle - 29G x 5/16 Thin Wall
K151398 · Terumo Europe N.V. · Jun 2015