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Infusion Pump Model 270

by Avi, Inc. 510(k)

Active United States

510(k) K872514

Overview

The Infusion Pump Model 270 is a medical device classified as an infusion pump, designed to deliver controlled volumes of fluids, such as medications or nutrients, to patients over time. It operates by precisely regulating the flow rate and ensuring accurate dosing, which is critical in clinical settings for intravenous therapy, hydration, or pain management.

This device is intended for use in general hospital settings and has received FDA 510(k) clearance under the traditional review pathway, classified as substantially equivalent to existing devices. Supplied as a reusable medical instrument, it requires proper sterilization and maintenance per manufacturer guidelines. The Model 270 adheres to regulatory standards outlined in regulation number 880.5725 and is categorized under product code FRN.

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 NumberK872514 Date16 Dec 1987ClearedStatusActive

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

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Questions

  • What is the Infusion Pump Model 270 used for?

    The Infusion Pump Model 270 is designed to deliver controlled volumes of fluids such as medications, nutrients, or hydration solutions to patients over time. Its precise flow regulation makes it ideal for intravenous therapy, hydration maintenance, and pain management in general hospital settings.

  • Is the Infusion Pump Model 270 reusable or single-use?

    The Infusion Pump Model 270 is supplied as a reusable medical instrument. It requires proper sterilization and maintenance per the manufacturer’s guidelines to ensure safe and effective use across multiple procedures.

  • What regulatory pathway was followed for the Infusion Pump Model 270?

    The Infusion Pump Model 270 received FDA 510(k) clearance through the traditional review pathway, demonstrating substantial equivalence to existing infusion pumps. It adheres to regulatory standards outlined in regulation number 880.5725 and is categorized under product code FRN.

  • How should the Infusion Pump Model 270 be stored?

    While the device data does not specify storage conditions, reusable medical devices like the Model 270 typically require clean, dry storage in a protected environment to prevent contamination. Follow the manufacturer’s instructions for optimal preservation and maintenance.

  • What types of clinical settings is the Infusion Pump Model 270 intended for?

    The Infusion Pump Model 270 is specifically intended for use in general hospital settings. Its design supports controlled fluid delivery in environments where precise dosing is critical, such as intensive care, surgical recovery, or chronic medication administration.