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Model 1001

by A0kfusion Systems, Inc. 510(k)

Active United States

510(k) K844718

Overview

The Model 1001 is a Class II infusion pump manufactured by A0kfusion Systems, Inc. It is designed for use in general hospital settings to deliver fluids to patients.

The Model 1001 is supplied as a reusable device and is not MRI safe. It is authorized under FDA 510(k) clearance with K number K844718, received on December 4, 1984, and deemed substantially equivalent on January 28, 1985.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK844718 Date28 Jan 1985ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the Model 1001 infusion pump used for?

    The Model 1001 is a Class II infusion pump designed for use in general hospital settings to deliver fluids to patients. It is manufactured by A0kfusion Systems, Inc.

  • Is the Model 1001 infusion pump single-use or reusable?

    The Model 1001 is supplied as a reusable device. It is not intended for single-use and can be used multiple times in appropriate clinical settings.

  • What is the regulatory status of the Model 1001 infusion pump?

    The Model 1001 is authorized under FDA 510(k) clearance with K number K844718, received on December 4, 1984, and deemed substantially equivalent on January 28, 1985.

  • Is the Model 1001 infusion pump MRI safe?

    No, the Model 1001 infusion pump is not MRI safe. It should not be used in MRI environments as it may pose safety risks.