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FDA 510(k)

Safety Insulin Pen Needles

K-Number: K213183 · 2022-10-14

ApplicantZhejiang Kindly Medical Devices Co., Ltd.
Decision Date2022-10-14
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Safety Insulin Pen Needles 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 2022-10-14 under 510(k) number K213183. 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 Insulin Pen Needles?

Safety Insulin Pen Needles is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Zhejiang Kindly Medical Devices Co., Ltd.. The 510(k) number is K213183.

When did Safety Insulin Pen Needles receive FDA 510(k) clearance?

Safety Insulin Pen Needles received FDA 510(k) clearance on 2022-10-14, under 510(k) number K213183.

Who is the listed applicant for Safety Insulin Pen Needles?

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 Safety Insulin Pen Needles?

The FDA product code for Safety Insulin Pen Needles 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 UseK181069Disposable Insulin Pen NeedleK172763Blood 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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