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Prominjet Pump

by Abbott Laboratories 510(k)

Active United States

510(k) K832120

Overview

The Prominjet Pump is an infusion pump device designed for medical use in general hospital settings. It is classified as a Class II medical device under product code FRN with special controls.

The device is manufactured by Abbott Laboratories and received FDA 510(k) clearance on August 12, 1983, with a decision of substantially equivalent. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK832120 Date12 Aug 1983ClearedStatusActive

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)

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

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Questions

  • What is the Prominjet Pump used for?

    The Prominjet Pump is an infusion pump device designed for medical use in general hospital settings. It is classified as a Class II medical device under product code FRN with special controls.

  • Is the Prominjet Pump single-use or reusable?

    The device data does not specify whether the Prominjet Pump is designed for single-use or reuse. No information regarding sterility or MRI safety is provided in the available specifications.

  • What is the regulatory status of the Prominjet Pump?

    The Prominjet Pump received FDA 510(k) clearance on August 12, 1983, with a decision of substantially equivalent. It is manufactured by Abbott Laboratories and classified as a Class II medical device under product code FRN with special controls.

  • What are the storage conditions for the Prominjet Pump?

    No information regarding storage conditions for the Prominjet Pump is provided in the device data. The available specifications focus on its classification, manufacturer, and regulatory clearance.