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I.V. Pump, Abbott/Shaw Lifecare

by Abbott Laboratories 510(k)

Active United States

510(k) K770087

Overview

The I.V. Pump, Abbott/Shaw Lifecare is an infusion pump designed for medical use in general hospital settings. It is a Class 2 medical device that delivers fluids intravenously to patients.

This device is manufactured by Abbott Laboratories and was cleared by the FDA through a 510(k) process on February 14, 1977, with the product code FRN and regulation number 880.5725. The device is substantially equivalent to predicate devices and is intended for use in hospital environments for intravenous fluid administration.

AI-generated from registry data, 27 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 NumberK770087 Date14 Feb 1977ClearedStatusActive

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

1 recall · FDA

    • Terminated Z-1350-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K770087, on the same 510(k)

    Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

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 I.V. Pump Abbott/Shaw Lifecare used for?

    The I.V. Pump Abbott/Shaw Lifecare is designed for medical use in general hospital settings to deliver fluids intravenously to patients. It is a Class 2 medical device intended for intravenous fluid administration in hospital environments.

  • Is the I.V. Pump Abbott/Shaw Lifecare a single-use or reusable device?

    The device data does not specify whether the I.V. Pump Abbott/Shaw Lifecare is single-use or reusable. This information would typically be found in the device's instructions for use or product specifications.

  • What is the regulatory status of the I.V. Pump Abbott/Shaw Lifecare?

    The I.V. Pump Abbott/Shaw Lifecare was cleared by the FDA through a 510(k) process on February 14, 1977. It is classified as a Class 2 medical device with product code FRN and regulation number 880.5725, and is substantially equivalent to predicate devices.

  • What sizes and models are available for the I.V. Pump Abbott/Shaw Lifecare?

    The device data does not provide information about specific sizes or models of the I.V. Pump Abbott/Shaw Lifecare. This information would typically be available in the product catalog or from the manufacturer directly.

  • How should the I.V. Pump Abbott/Shaw Lifecare be stored?

    The device data does not specify storage requirements for the I.V. Pump Abbott/Shaw Lifecare. Storage instructions would typically be provided in the device's instructions for use or product documentation.