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Volumetric Infusion Pump

by Kendall Mcgaw Laboratories, Inc.

510(k) K904518

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

37 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK904518 Date17 Oct 1990ClearedStatusActive

Recalls

37 recalls · FDA

    • Terminated Z-2552-2021 FDA Class II initiated 10 Aug 2021 on shared 510(k) K904518

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    • Terminated Z-2166-2013 FDA Class II initiated 5 Aug 2013

    Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection sites and corresponding low pressure backcheck valve was assembled upside down.

  • 27 recalls, same reason

    • Terminated Z-0692-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0689-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0676-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0690-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0698-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0675-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0717-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0680-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0711-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0715-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0712-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0697-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0683-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0687-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0716-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0713-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0688-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0709-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0682-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0679-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0694-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0703-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0681-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0691-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0714-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0693-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518
    • Terminated Z-0710-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K904518

    System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the set to be used. This requires a new set to be obtained, thus creating a potential for delay in therapy.

  • 2 recalls, same reason

    • Terminated Z-1431-2009 FDA Unclassified (pre-2012) initiated 27 Mar 2009 on shared 510(k) K904518
    • Terminated Z-1428-2009 FDA Unclassified (pre-2012) initiated 27 Mar 2009 on shared 510(k) K904518

    Device defect is occlusion/no flow.

  • 4 recalls, same reason

    • Terminated Z-2409-2008 FDA Unclassified (pre-2012) initiated 30 Jun 2008
    • Terminated Z-2410-2008 FDA Unclassified (pre-2012) initiated 30 Jun 2008 on shared 510(k) K904518
    • Terminated Z-2408-2008 FDA Unclassified (pre-2012) initiated 30 Jun 2008
    • Terminated Z-2407-2008 FDA Unclassified (pre-2012) initiated 30 Jun 2008

    incorrect burette was packaged with the product

  • 2 recalls, same reason

    • Terminated Z-0818-2007 FDA Unclassified (pre-2012) initiated 18 Apr 2007 on shared 510(k) K904518
    • Terminated Z-0819-2007 FDA Unclassified (pre-2012) initiated 18 Apr 2007 on shared 510(k) K904518

    Secondary infusion backs up into primary container.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Volumetric Infusion Pump is an infusion pump designed to deliver fluids into a patient in a controlled manner. It functions by regulating the volume of fluid administered over a specific period.

This device is classified as a Class 2 medical device under regulation number 880.5725. It has received FDA 510(k) clearance for use in a general hospital setting.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Volumetric Infusion Pump?

    This device is designed to deliver fluids into a patient in a controlled manner by regulating the specific volume of fluid administered over a set period.

  • In what clinical environment is this pump intended to be used?

    The device has received FDA 510(k) clearance specifically for use within a general hospital setting.

  • How is this device classified for regulatory purposes?

    The Volumetric Infusion Pump is classified as a Class 2 medical device under regulation number 880.5725.