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Horizon Outlook With Dosecom

by B. Braun Medical, Inc.

510(k) K011975

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK011975 Date19 Sep 2001ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-2188-2013 FDA Class I initiated 14 Nov 2012

    This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on August 26, 2011 due to an issue in which the Outlook ES Safety Infusion System may halt infusion but the "RUN" Light Emitting Diodes (LEDs) on the front display continue to advance as if the pump were infusing. The pump emits a backup alarm, but there are no visual indicators that the infusion

    • Terminated Z-0051-2012 FDA Unclassified (pre-2012) initiated 7 Sep 2011

    B Braun Outlook ES Safety Infusion System "Run" Light Emitting Diodes (LEDs) pumps stop infusing and a backup alarm sounds, but the "Run" LEDs advance as if the pumps were infusing.

    • Terminated Z-0837-2011 FDA Unclassified (pre-2012) initiated 24 Aug 2010

    Possible pump stop with audible alarm, but no visual error indication that the pump is not delivering the medication. Under certain conditions in a network environment, Management Processor may become non-responsive, ceasing normal operation.

    • Terminated Z-0007-2012 FDA Unclassified (pre-2012) initiated 20 Jul 2010

    The Outlook ES Dose Guard Care Area can inadvertently be exited when the pump enters the KVO (Keep Vein Open) state. The same condition can occur when a sequence of HOLD-HOLD key strokes are performed on the pump key panel.

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  • Withdrawn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
FDA applicant
B.Braun Medical, Inc.
Device class
Class II
Regulation
21 CFR Part 880.5725
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Horizon Outlook With Dosecom is an electrical, external volumetric infusion pump intended to provide infusions of parenteral fluids. It is classified as a Class II medical device under regulation number 880.5725 and has received FDA 510(k) clearance as substantially equivalent to a predicate device.

The device is intended for use in hospital and/or nursing home (extended care) settings. It is supplied as a non-sterile, reusable device and requires operation by trained healthcare professionals or authorized representatives. No information regarding MRI safety, specific sizes, storage conditions, or single-use status is provided in the data.

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Questions

AI-generated answers, 21 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 Horizon Outlook With Dosecom used for?

    The Horizon Outlook With Dosecom is an electrical, external volumetric infusion pump intended to provide infusions of parenteral fluids in hospital and/or nursing home (extended care) settings, requiring operation by trained healthcare professionals or authorized representatives.

  • Is the Horizon Outlook With Dosecom sterile or non-sterile, and is it single-use or reusable?

    The device is supplied as a non-sterile, reusable device, meaning it is not provided in a sterile condition and is designed for multiple uses after appropriate cleaning and reprocessing by trained personnel.

  • What regulatory pathway was used for the Horizon Outlook With Dosecom?

    The Horizon Outlook With Dosecom received FDA 510(k) clearance as substantially equivalent to a predicate device, classified as a Class II medical device under regulation number 880.5725.