FDA 510(k)

Pen Injector Needle 32.5

K-Number: K250700 · 2025-11-21

Decision Date2025-11-21

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Pen Injector Needle 32.5 is a medical device manufactured by Terumo Corporation. It received FDA 510(k) clearance on 2025-11-21 under approval number K250700. 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 Pen Injector Needle 32.5?

Pen Injector Needle 32.5 is a medical device that received FDA 510(k) clearance on 2025-11-21. It is manufactured by Terumo Corporation. The 510(k) number is K250700.

When was Pen Injector Needle 32.5 approved by the FDA?

Pen Injector Needle 32.5 received FDA 510(k) clearance on 2025-11-21, under approval number K250700.

What company makes Pen Injector Needle 32.5?

Pen Injector Needle 32.5 is manufactured by Terumo Corporation.

What is the FDA product code for Pen Injector Needle 32.5?

The FDA product code for Pen Injector Needle 32.5 is FMI.

Other Devices by Terumo Corporation

K170417Glidewire GT K181369Immucise Intradermal Injection System K173799NaviCross 0.018 K190427Immucise K240818R2P Radifocus Glidewire Advantage K240859Glidewire GT-R

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.