FDA 510(k)

BD Pen Needle

K-Number: K213478 · 2022-06-28

Decision Date2022-06-28

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BD Pen Needle is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2022-06-28 under approval number K213478. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Pen Needle?

BD Pen Needle is a medical device that received FDA 510(k) clearance on 2022-06-28. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K213478.

When was BD Pen Needle approved by the FDA?

BD Pen Needle received FDA 510(k) clearance on 2022-06-28, under approval number K213478.

What company makes BD Pen Needle?

BD Pen Needle is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD Pen Needle?

The FDA product code for BD Pen Needle is FMI.

Other Devices by Becton, Dickinson and Company

K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe K162516BD Pen Needle K160657BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube K151589BD MAX CT/GC/TV, BD MAX INSTRUMENT K151870BD U-500 INSULIN SYRINGE K161553BD SafeAssist

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Related Devices (Code: FMI)

K162516BD Pen NeedleBecton, Dickinson and Company K160532Greiner HoldexGreiner Bio-One Na, Inc. K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. K151090CPL Insulin Pen NeedleCpl Co., Ltd. K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc. K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.