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Disposable Insulin Syringe

by Hantech Medical Device Co., Ltd. China 510(k)

510(k) K222672 Product code FMF

Overview

A disposable insulin syringe is a medical device designed for the subcutaneous administration of insulin. It consists of a graduated barrel, plunger, and needle, intended for single-use delivery of prescribed insulin doses.

This device is supplied sterile and intended for single-use only. It is used in general hospital or home care settings by patients or healthcare providers. The syringe is not MRI safe and should be stored according to manufacturer instructions. Authorization is based on FDA 510(k) clearance under product code FMF, with K-number K222672.

Summary written by AI from registry data, 21 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK222672 Date6 Mar 2023ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Hantech Medical Device Co., Ltd.

See all devices from Hantech Medical Device Co., Ltd. →

Questions

  • What is the Disposable Insulin Syringe used for?

    It is designed for the subcutaneous administration of insulin, allowing patients or healthcare providers to deliver prescribed insulin doses accurately using its graduated barrel and plunger.

  • Is the Disposable Insulin Syringe sterile and for single-use only?

    Yes, the device is supplied sterile and intended for single-use only, as stated in its description, to prevent contamination and ensure safe insulin delivery.

  • Where can the Disposable Insulin Syringe be used?

    It is used in general hospital or home care settings by patients or healthcare providers for insulin administration, as specified in the device description.

  • What regulatory pathway was used for the Disposable Insulin Syringe?

    The device received FDA 510(k) clearance under product code FMF with K-number K222672, based on a traditional submission demonstrating substantial equivalence.

  • Is the Disposable Insulin Syringe safe for use in MRI environments?

    No, the syringe is not MRI safe, as explicitly noted in the device data, so it should not be brought into MRI suites or strong magnetic fields.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K222672 24 fields · synced 22 Oct 2026