FDA 510(k)

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)

K-Number: K202319 · 2021-11-12

ApplicantTianjin Huahong Technology Co., Ltd.

Decision Date2021-11-12

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Huahong Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-12 under 510(k) number K202319. 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 Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)?

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) is a medical device that received FDA 510(k) clearance on 2021-11-12. The listed applicant is Tianjin Huahong Technology Co., Ltd.. The 510(k) number is K202319.

When did Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) receive FDA 510(k) clearance?

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) received FDA 510(k) clearance on 2021-11-12, under 510(k) number K202319.

Who is the listed applicant for Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)?

The FDA 510(k) record lists Tianjin Huahong Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)?

The FDA product code for Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) is FMI.

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NCT06406439DIA:CONN P8(Smart Insulin Pen) Study in Diabetes PatientsCOMPLETED

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Related Devices (Code: FMI)

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

View on FDA Database →

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