510(k) · Cleared
Recalled · Class I · 2012Horizon Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · FRN Pump, Infusion
Cleared on Mar 8, 2000 as substantially equivalent to K904518 (Kendall Mcgaw Laboratories, Inc., 1990) and 1 other predicate after a 72-day review. Its family tree reaches back 1 generation to 1990. 17 of the 68 devices in its family, counting itself, have a Class I recall. 65 later devices descend from it. It has been recalled 5 times, including a Class I recall.
- Decided
- Mar 8, 2000
- Review
- 72 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 5 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904518 (1990). 2 ancestors in all. 65 later devices descend from it, 3 citing it directly. 17 of the 68 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- This deviceK994375 Horizon LightB.Braun Medical, Inc. · 2000
- Descendant · cites it directly · 49 of its ownK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- Descendant · 2 generations on · 28 of its ownK042121 Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Recalled (Class I)
- Descendant · 3 generations on · 18 of its ownK133801 Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · Recalled (Class I)
- Descendant · cites it directly · 16 of its ownK023189 Vista Basic with FM SystemB.Braun Medical, Inc. · 2003
- Descendant · 2 generations on · 15 of its ownK062700 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · Recalled (Class I)
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 65 · See all- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · cites it directly49descendants
- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · 2 generations on28descendants
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 3 generations on18descendants
- K023189Vista Basic with FM SystemB.Braun Medical, Inc. · 2003 · cites it directly16descendants
- K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| 0 (this device) | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | — |
| +1 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| +2 | K042121 | Spectrum and Spectrum with Master Drug Library | Sigma Intl. | 2004 | Class I |
| +3 | K133801 | Baxter Sigma Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2014 | Class I |
| +1 | K023189 | Vista Basic with FM System | B.Braun Medical, Inc. | 2003 | — |
| +2 | K062700 | Infusomat Space Volumetric Infusion Pump System | B.Braun Medical, Inc. | 2006 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 1 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 2 |
| 2005 | 1 | 0 |
| 2006 | 2 | 1 |
| 2007 | 1 | 0 |
| 2009 | 3 | 1 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 1 |
| 2014 | 7 | 2 |
| 2015 | 2 | 1 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 1 |
| 2019 | 2 | 1 |
| 2020 | 5 | 2 |
| 2021 | 2 | 0 |
| 2022 | 7 | 0 |
| 2023 | 4 | 2 |
| 2024 | 3 | 1 |
| 2025 | 6 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
17 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K904518 | Volumetric Infusion PumpSummary page 1…B. Braun Medical Inc. is claiming substantial equivalence' to is the Horizon® Modular Infusion System, currently marketed by B. Braun Medical Inc. under cleared 510(k) K904518. The Barcode Reader that B. Braun Medical Inc. is claiming substantial equivalence to is part of the Verifuse® Multi-Mode Ambul… | 1990 |
| * | K934551 | Verifuse Ambulatory PumpSummary page 1…. Braun Medical Inc. is claiming substantial equivalence to is part of the Verifuse® Multi-Mode Ambulatory Infusion Pump, marketed by Block Medical under cleared 510(k) K934551. ! The term "substantially equivalent" as used herein is intended to be a determination of substantial equivalence from an FDA -… | 1994 |
What descends from it? (65)
See all 653 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (17 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 5, 2012 | Class II | Z-2175-2013 | Component design/selection | 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 occurred after periods of lost DC… |
| Nov 14, 2012 | Class I | Z-2188-2013 | Software design | 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… |
| Sep 7, 2011 | Not classified | Z-0051-2012 | Software design | 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 | Component design/selection | 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… |
| Jul 20, 2010 | Not classified | Z-0007-2012 | Software design | 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. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Cites it directly · ◆ in the 2001 descendants bar of FIG. 11 Class I recall
- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 13 Class I recalls
- K041241Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 15 Class I recalls
- K191910SpaceStation MRIB. Braun Melsugen AG · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
- K142036Infusomat Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K121613Agilia Infusion SystemFresenius Kabi AG · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K142596Infusomat Space Volumetric Infusion PumpB.Braun Medical, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
- K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K230022Baxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 16 shown.
Nearest 5 of 16; all are on the web page.
What does this lineage say?
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
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…
Read the full statement (181 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994375: Horizon Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994375
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026