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FDA 510(k)

SureFine Pen Needle

K-Number: K250658 · 2025-04-03

ApplicantShina Med Corporation
Decision Date2025-04-03
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SureFine Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Shina Med Corporation. It received FDA 510(k) clearance on 2025-04-03 under 510(k) number K250658. 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 SureFine Pen Needle?

SureFine Pen Needle is a medical device that received FDA 510(k) clearance on 2025-04-03. The listed applicant is Shina Med Corporation. The 510(k) number is K250658.

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

SureFine Pen Needle received FDA 510(k) clearance on 2025-04-03, under 510(k) number K250658.

Who is the listed applicant for SureFine Pen Needle?

The FDA 510(k) record lists Shina Med Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SureFine Pen Needle?

The FDA product code for SureFine Pen Needle is FMI.

Other records listing Shina Med Corporation 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.

K250510Sure-Fine Insulin SyringesK231165Shina Syringe; Shina Safety SyringeK210848Sure-Fine Insulin SyringesK191531Sure-Fine Insulin SyringesK152879Sure-Fine Insulin SyringesK152877SureFine Pen Needle

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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

View on FDA Database →

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

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