Cleared Traditional

K213478 - BD Pen Needle

K213478 is an FDA 510(k) clearance for BD Pen Needle, manufactured by Becton, Dickinson and Company. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K213478

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.

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 455
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