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FDA 510(k)

Disposable Insulin Pen Needle

K-Number: K181069 · 2018-08-28

ApplicantZhejiang Kindly Medical Devices Co., Ltd.
Decision Date2018-08-28
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Insulin Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Kindly Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2018-08-28 under 510(k) number K181069. 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 Disposable Insulin Pen Needle?

Disposable Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2018-08-28. The listed applicant is Zhejiang Kindly Medical Devices Co., Ltd.. The 510(k) number is K181069.

When did Disposable Insulin Pen Needle receive FDA 510(k) clearance?

Disposable Insulin Pen Needle received FDA 510(k) clearance on 2018-08-28, under 510(k) number K181069.

Who is the listed applicant for Disposable Insulin Pen Needle?

The FDA 510(k) record lists Zhejiang Kindly Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Insulin Pen Needle?

The FDA product code for Disposable Insulin Pen Needle is FMI.

Other records listing Zhejiang Kindly Medical Devices Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223334Sterile Hypodermic Needles for Single UseK213183Safety Insulin Pen NeedlesK172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with HolderK171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles

Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech Co., Ltd.

Official Source

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

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