Cleared Traditional

K152824 - MEDT PEN NEEDLE

K152824 is an FDA 510(k) clearance for MEDT PEN NEEDLE, manufactured by Shandong Caremed Medical Products Co., Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K152824 · Shandong Caremed Medical Products Co., Ltd. · General Hospital
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Mar 2016
Decision
160d
Days
Class 2
Risk

K152824 is an FDA 510(k) clearance for the MEDT PEN NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Shandong Caremed Medical Products Co., Ltd. (Heze, CN). The FDA issued a Cleared decision on March 7, 2016 after a review of 160 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 Shandong Caremed Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K152824

510(k) Number K152824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2015
Decision Date March 07, 2016
Days to Decision 160 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
31d slower than avg
Panel avg: 129d · This submission: 160d
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 305
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K152824.
Cook Intraosseous Infusion Needles
K160887 · Cook Incorporated · Jul 2016
BD SafeAssist
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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
K-Pack II Needle-21G x 2
K150263 · Terumo Europe N.V. · Apr 2015
EZ-IO INTRAOSSEOUS INFUSION SYSTEM
K132583 · Vidacare Corporation · Feb 2014