FDA 510(k)

Insulin Pen Needle

K-Number: K221176 · 2022-07-01

ApplicantTianjin Huahong Technology Co., Ltd.

Decision Date2022-07-01

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Insulin Pen Needle is a medical device manufactured by Tianjin Huahong Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-01 under approval number K221176. 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?

Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2022-07-01. It is manufactured by Tianjin Huahong Technology Co., Ltd.. The 510(k) number is K221176.

When was Insulin Pen Needle approved by the FDA?

Insulin Pen Needle received FDA 510(k) clearance on 2022-07-01, under approval number K221176.

What company makes Insulin Pen Needle?

Insulin Pen Needle is manufactured by Tianjin Huahong Technology Co., Ltd..

What is the FDA product code for Insulin Pen Needle?

The FDA product code for Insulin Pen Needle is FMI.

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Other Devices by Tianjin Huahong Technology Co., Ltd.

K202319Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) K220372Heel Stick Safety Lancet (HHZ-II, HHZ-III) K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) K241627Safety Lancet (XXXV)

View all 12 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.