510(k) · Cleared
Recalled · Class I · 2012Horizon Outlook with Dosecom
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 Sep 19, 2001 as substantially equivalent to K994375 (B.Braun Medical, Inc., 2000) after an 86-day review. Its family tree reaches back 2 generations to 1990. 14 of the 53 devices in its family, counting itself, have a Class I recall. 49 later devices descend from it. It has been recalled 4 times, including a Class I recall.
- Decided
- Sep 19, 2001
- Review
- 86 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 4 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K904518 (1990). 3 ancestors in all. 49 later devices descend from it, 5 citing it directly. 14 of the 53 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 1 generation backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- This deviceK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001
- Descendant · cites it directly · 28 of its ownK042121 Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Recalled (Class I)
- Descendant · 2 generations on · 18 of its ownK133801 Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · Recalled (Class I)
- Descendant · 3 generations on · 9 of its ownK173084 Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · Recalled (Class I)
- Descendant · 2 generations on · 7 of its ownK123049 Sapphire Infusion PumpQ Core Medical, Ltd. · 2013
- Descendant · cites it directly · 7 of its ownK041241 Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 2004 · Recalled (Class I)
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 49 · See all- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · cites it directly28descendants
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 2 generations on18descendants
- K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · 3 generations on9descendants
- K123049Sapphire Infusion PumpQ Core Medical, Ltd. · 2013 · 2 generations on7descendants
- K041241Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 2004 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −1 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| 0 (this device) | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | — |
| +1 | K042121 | Spectrum and Spectrum with Master Drug Library | Sigma Intl. | 2004 | Class I |
| +2 | K133801 | Baxter Sigma Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2014 | Class I |
| +3 | K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software | Baxter Healthcare Corporation | 2018 | Class I |
| +2 | K123049 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2013 | — |
| +1 | K041241 | Medley System with Bar Code Module, Model 8600 | Alaris Medical Systems, Inc. | 2004 | 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 |
|---|---|---|
| 2004 | 3 | 2 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 1 |
| 2011 | 1 | 0 |
| 2013 | 2 | 1 |
| 2014 | 5 | 1 |
| 2015 | 2 | 1 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 1 |
| 2019 | 2 | 1 |
| 2020 | 2 | 1 |
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 2 |
| 2024 | 3 | 1 |
| 2025 | 5 | 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.
14 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? (1)
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 |
|---|---|---|---|
| * | K994375 | Horizon LightSummary page 1…ce that B. Braun Medical Inc. 1s claiming substantial equivalence' to is the Horizon Outlook™ with DoseScan™, (formerly named Horizon® Lite) marketed under cleared 510(k)994375 by B. Braun Medical Inc. Horizon Outlook™ with DoseScan™ is an electrical, external, volumetric infusion pump. There are no new i… | 2000 |
What descends from it? (49)
See all 495 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042121 | Spectrum and Spectrum with Master Drug Library Class I | 2004 | 28 |
| K041241 | Medley System with Bar Code Module, Model 8600 Class I | 2004 | 7 |
| K083689 | Infusomat Space Volumetric Infusion Pump System Class I | 2009 | 4 |
| K042609 | Hospira Mednet Medication Management Suite | 2004 | 4 |
| K092313 | Perfusor Space Infusion Syringe Pump System | 2009 | 1 |
Has anything in its family been recalled? (14 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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.
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 13 Class I recalls
- K041241Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 15 Class I recalls
- K142596Infusomat Space Volumetric Infusion PumpB.Braun Medical, Inc. · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
- K121613Agilia Infusion SystemFresenius Kabi AG · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 3 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 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
- K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 14 Class I recalls
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls
- K211122Novum IQ Large Volume PumpBaxter Healthcare Corporation · 2024 · 4 generations on · ◆ in the 2024 descendants bar of FIG. 13 Class I recalls
Nearest 12 of 13 shown.
Nearest 5 of 13; all are on the web page.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- 2 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K042121 (Sigma Intl., 2004) has gone furthest, with 28 descendants of its own.
- 2 other devices also cite its predicate K994375.
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 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…
Read the full statement (164 words)
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.
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/K011975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011975: Horizon Outlook with Dosecom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011975
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026