Cleared Traditional

K213478 - BD Pen Needle

K213478 is the FDA 510(k) clearance for BD Pen Needle by Becton, Dickinson and Company. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K213478 · Becton, Dickinson and Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
242d
Days
Class 2
Risk

K213478 is an FDA 510(k) clearance for the BD 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 June 28, 2022 after a review of 242 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 Becton, Dickinson and Company devices

Submission Details

510(k) Number K213478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2021
Decision Date June 28, 2022
Days to Decision 242 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
113d slower than avg
Panel avg: 129d · This submission: 242d
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 235
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K213478.
Disposable Medical Safety Hypodermic Needle
K220603 · Hantech Medical Device Co., Ltd. · Aug 2022
SurGuard3 Safety Hypodermic Needle
K212095 · Terumo Europe N.V. · Aug 2022
Insulin Pen Needle
K221176 · Tianjin Huahong Technology Co., Ltd. · Jul 2022
MEDOJECT fine Pen Needles
K220614 · Chirana T. Injecta · Jun 2022
Well-life TM Pen Needles, Well-life TM Safety Pen Needles
K210748 · W. L. Med Co., Ltd. · May 2022
Sterile Safety Hypodermic Needles for Single Use
K213535 · Zhejiang Kangkang Medical-Devices Co., Ltd. · May 2022