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Allison Medical Insulin Syringe (AMIS)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K984017

by Allison Medical, Inc.

Identifiers

510(k) Number
K984017 FDA 510(k)
FDA Product Code
FMF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5860 FDA 510(k)
Regulation Number
880.5860 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Allison Medical Insulin Syringe (AMIS) is a manual, single-use, sterile hypodermic syringe classified under the nomenclature for insulin delivery devices. It is designed specifically for subcutaneous insulin administration, featuring a barrel, plunger, and needle assembly to facilitate precise dosing.

Intended for use in both home and clinical settings, the AMIS is supplied sterile and intended for one-time use only. It requires no regulatory approval beyond its FDA 510(k) clearance (K984017), with no additional MRI safety or reprocessing requirements. The device adheres to standard hypodermic syringe specifications and is distributed as a disposable medical item.

This description and any FAQs above were generated automatically from registry data 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. Sources consulted: Quality Diabetes & Animal Health Products - Allison Medical, ALLISON MEDICAL INSULIN SYRINGE (AMIS) (K984017) - Innolitics, Diabetes Health - Allison Medical, K984017 FDA 510(k) - ALLISON MEDICAL INSULIN SYRINGE (AMIS)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Allison Medical, Inc.

Sources (1)

  • FDA 510(k) K984017 24 fields · synced Sep 19, 2026