Cleared Traditional

BD Nano 2nd Gen Pen Needle (K212015) - FDA 510(k) Clearance

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

K212015 · Becton, Dickinson and Company · General Hospital
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Nov 2021
Decision
144d
Days
Class 2
Risk

K212015 is an FDA 510(k) clearance for the BD Nano 2nd Gen Pen Needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on November 19, 2021 after a review of 144 days - within the typical 510(k) review window.

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 Becton, Dickinson and Company devices

Submission Details

510(k) Number K212015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2021
Decision Date November 19, 2021
Days to Decision 144 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
15d slower than avg
Panel avg: 129d · This submission: 144d
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 Peers - FMI Needle, Hypodermic, Single Lumen

All 195
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K212015.
UltiCare Disposable Pen Needles
K213407 · Ultimed Incorporated · Dec 2021
Blood Collection Needles
K200932 · Vacutest Kima Srl · Dec 2021
BD Nano 2nd Gen Pen Needle
K213156 · Becton, Dickinson and Company · Dec 2021
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
K202319 · Tianjin Huahong Technology Co., Ltd. · Nov 2021
Sterile Hypodermic Needles for Single Use
K211214 · Azur Medical Company, Inc. · Oct 2021
SteriCap Mini Needle and Standard Needles
K212805 · Ocuject, LLC · Sep 2021