# K011975: Horizon Outlook with Dosecom

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Sep 19, 2001 after 86 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904518 (1990). 3 ancestors in all.
49 later devices descend from it; 5 cite it directly.
14 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994375: Horizon Light, B.Braun Medical, Inc. (2000) Summary page 1.

## Most influential descendants
- K042121: Spectrum and Spectrum with Master Drug Library (2004), 28 descendants of its own
- K133801: Baxter Sigma Spectrum Infusion Pump with Master Drug Library (2014), 18 descendants of its own
- K173084: Spectrum IQ Infusion System, Dose IQ Safety Software (2018), 9 descendants of its own
- K123049: Sapphire Infusion Pump (2013), 7 descendants of its own
- K041241: Medley System with Bar Code Module, Model 8600 (2004), 7 descendants of its own

## Recalls of this device
- Nov 14, 2012 · Class I · Z-2188-2013: 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 infusio
- Sep 7, 2011 · Not classified · Z-0051-2012: 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.
- Aug 24, 2010 · Not classified · Z-0837-2011: 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
- Jul 20, 2010 · Not classified · Z-0007-2012: 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

## Indications for use
The Horizon Outlook™ with DoseCom™ is an electrical, external volumetric infusion pump intended to provide infusions of parenteral fluids. Parenteral fluids may include all standard fluids and/or medications indicated for infusion as well as blood and blood products. Adjustable occlusion pressure settings allow arterial, epidural and intrathecal infusions. The system created by using dedicated cassettes is intended to provide accurate and continuous flow of these fluids to the patient. The Horizon Outlook™ with DoseCom™ is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician’s order. The Horizon Outlook™ with DoseCom™ is intended for but not limited to use in the hospital, and/or nursing home (extended care) settings. The Horizon Outlook™ with DoseCom™ is intended for use by trained healthcare providers in accordance with the instructions provided in the Operation Manual.

Source page: https://510kreport.com/device/K011975
Methodology: https://510kreport.com/methodology