Cleared Traditional

K211214 - Sterile Hypodermic Needles for Single Use

K211214 is an FDA 510(k) clearance for Sterile Hypodermic Needles for Single Use, manufactured by Azur Medical Company, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K211214 · Azur Medical Company, Inc. · General Hospital
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Oct 2021
Decision
174d
Days
Class 2
Risk

K211214 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 Azur Medical Company, Inc. (Richmond, US). The FDA issued a Cleared decision on October 14, 2021 after a review of 174 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 Azur Medical Company, Inc. devices

FDA 510(k) Submission Details - K211214

510(k) Number K211214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2021
Decision Date October 14, 2021
Days to Decision 174 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
45d slower than avg
Panel avg: 129d · This submission: 174d
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 271
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K211214.
BD Nano 2nd Gen Pen Needle
K213156 · Becton, Dickinson and Company · Dec 2021
BD Nano 2nd Gen Pen Needle
K212015 · Becton, Dickinson and Company · Nov 2021
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
K202319 · Tianjin Huahong Technology Co., Ltd. · Nov 2021
SteriCap Mini Needle and Standard Needles
K212805 · Ocuject, LLC · Sep 2021
Sterile Hypodermic Needles for Single Use
K210232 · Zhejiang Kangkang Medical-Devices Co., Ltd. · Sep 2021
Unifine SafeControl
K210399 · Owen Mumford, Ltd. · Sep 2021