# K994375: Horizon Light

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Mar 8, 2000 after 72 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 5 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904518 (1990). 2 ancestors in all.
65 later devices descend from it; 3 cite it directly.
17 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904518: Volumetric Infusion Pump, Kendall Mcgaw Laboratories, Inc. (1990) Summary page 1.
- K934551: Verifuse  Ambulatory Pump, Block Medical, Inc. (1994) Summary page 1.

## Most influential descendants
- K011975: Horizon Outlook with Dosecom (2001), 49 descendants of its own
- 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
- K023189: Vista Basic with FM System (2003), 16 descendants of its own
- K062700: Infusomat Space Volumetric Infusion Pump System (2006), 15 descendants of its own

## Recalls of this device
- Dec 5, 2012 · Class II · Z-2175-2013: B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This could have occu
- 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® Lite is an electrical, external volumetric infusion pump that provides infusions of parenteral fluids. The pump may be used to infuse all intravenous medications, blood, and blood components. 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 pump is software controlled and operates using volumetric displacement with a stepper-motor mechanism. The new incorporation of a Barcode Reading System is intended to decrease the incidence of medication errors. The Barcode Reader provides a method to automate the implementation of an infusion by verifying nurse and patient identifications and transferring infusion parameters to the pump. The Horizon® Lite is intended for but not limited to use in the hospital, home care and/or nursing home (extended care) settings. The Horizon® Lite is intended for use by trained healthcare providers in accordance with the instructions provided in the Operation Manual. All data entry and validation of the Horizon® Lite is performed by the trained healthcare provider per a physician’s order.

Source page: https://510kreport.com/device/K994375
Methodology: https://510kreport.com/methodology