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FDA 510(k)

Safety Pen Needle for Single Use, Insulin Pen Needles

K-Number: K212514 · 2022-04-29

ApplicantBerpu Medical Technology Co., Ltd.
Decision Date2022-04-29
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Safety Pen Needle for Single Use, Insulin Pen Needles is a medical device manufactured by Berpu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-04-29 under approval number K212514. 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 Safety Pen Needle for Single Use, Insulin Pen Needles?

Safety Pen Needle for Single Use, Insulin Pen Needles is a medical device that received FDA 510(k) clearance on 2022-04-29. It is manufactured by Berpu Medical Technology Co., Ltd.. The 510(k) number is K212514.

When was Safety Pen Needle for Single Use, Insulin Pen Needles approved by the FDA?

Safety Pen Needle for Single Use, Insulin Pen Needles received FDA 510(k) clearance on 2022-04-29, under approval number K212514.

What company makes Safety Pen Needle for Single Use, Insulin Pen Needles?

Safety Pen Needle for Single Use, Insulin Pen Needles is manufactured by Berpu Medical Technology Co., Ltd..

What is the FDA product code for Safety Pen Needle for Single Use, Insulin Pen Needles?

The FDA product code for Safety Pen Needle for Single Use, Insulin Pen Needles is FMI.

Related Clinical Trials

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 41090443 Confirmatory evidence supporting single pivotal trial new drug approvals by the Food and Drug Administration, 2015 through 2023. Clinical trials (London, England) (2026)

Other Devices by Berpu Medical Technology Co., Ltd.

K162180Disposable Insulin Syringe K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use K181447Safety insulin needle for single use K221045Insulin Syringes without needle K220061Safety Insulin Syringes K213158Syringe with permanently attached needle

View all 9 devices →

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.

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