Model 3000 Infusion Pump

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K871881 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

• Qbc System Hemoglobin

  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

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• What is the Model 3000 Infusion Pump used for?

  The Model 3000 Infusion Pump is designed for general hospital use to deliver fluids to patients in a controlled manner. It is a Class II medical device that provides precise fluid administration for various clinical applications.

• Is the Model 3000 Infusion Pump single-use or reusable?

  The device is supplied as a single unit and is not specified as either single-use or reusable in the product information. The manufacturer's instructions should be consulted for specific guidance on reuse or disposal protocols.

• What regulatory approvals does the Model 3000 Infusion Pump have?

  The Model 3000 Infusion Pump has FDA 510(k) clearance with the K number K871881. It is regulated under product code FRN with regulation number 880.5725 and is classified as a Class II medical device.

• Is the Model 3000 Infusion Pump MRI safe?

  The device is not indicated as MRI safe in the provided information. Healthcare facilities should verify MRI compatibility requirements with the manufacturer before using the device in MRI environments.