Model 2001 Modification

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K905029 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Ambulatory Infusion Pump

  Class II

  FDA 510(k) K890862 Active Cleared 3 Aug 1989

• Modified Walkmed 400

  Class II

  FDA 510(k) K905783 Active Cleared 11 Jan 1991

• Model 3001 Syringe Infusion Pump

  Class II

  FDA 510(k) K901755 Active Cleared 29 Aug 1990

• Syringe Infusion Pump

  Class II

  FDA 510(k) K890120 Active Cleared 27 Jul 1989

• Is the Model 2001 Modification infusion pump intended for use in outpatient clinics, or is it strictly for hospital settings?

  The Model 2001 Modification is explicitly authorized for use in general hospital settings only, as indicated by its advisory committee description and regulatory filing. While it may not be explicitly excluded from other environments, its design and regulatory classification (Class II, FDA 510(k)) align with controlled hospital infusion needs, such as intravenous therapy administration. Always verify local protocols before use outside hospitals.

• How many patients can the Model 2001 Modification infusion pump serve before requiring maintenance or cleaning?

  The device is intended for single-patient use per cycle, meaning it should not be reused without proper cleaning and maintenance between patients. This ensures hygiene and reliability, as outlined in its reusable medical instrument classification and regulatory context (FDA 510(k) K905029). Follow manufacturer guidelines for reprocessing to maintain performance and compliance.

• What types of fluids or medications can the Model 2001 Modification infusion pump deliver, and are there any restrictions?

  The Model 2001 Modification is designed to deliver controlled volumes of fluids, including medications or solutions, at precise rates for intravenous therapies. While the device itself does not restrict specific fluid types, its use must comply with hospital protocols and clinical guidelines for compatibility (e.g., viscosity, pH, or additives). Always verify compatibility with the connected tubing and infusion set to avoid malfunctions or patient harm.

• Does the Model 2001 Modification infusion pump come with pre-assembled components, or does it require assembly before use?

  The device is supplied as a reusable medical instrument, implying it may require assembly or preparation before clinical use, such as attaching tubing, cassettes, or other accessories. The exact assembly steps depend on the manufacturer’s instructions, but the reusable nature suggests it is not a fully pre-packaged single-use device. Check the included documentation for specific setup procedures.

• What regulatory pathway was followed for the FDA clearance of the Model 2001 Modification, and how does this affect its use in clinical settings?

  The Model 2001 Modification received FDA 510(k) clearance (K905029) under a *Traditional* review pathway, determined to be *Substantially Equivalent* to a predicate device. This clearance confirms its safety and effectiveness for general hospital infusion pump applications, including intravenous therapies. Clinicians should adhere to the approved indications (as filed under product code FRN) and follow the manufacturer’s instructions for use to ensure compliance with regulatory requirements.