510(k) · Cleared
Recalled · Class II · 2021Volumetric Infusion Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kendall Mcgaw Laboratories, Inc. · FRN Pump, Infusion
Cleared on Oct 17, 1990 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 of the 68 devices in its family, counting itself, have a Class I recall. 67 later devices descend from it. It has been recalled 37 times.
- Decided
- Oct 17, 1990
- Review
- 14 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 37
- Predicates
- 0
67 later devices descend from it, 2 citing it directly. 17 of the 68 devices in this family, counting this one, have a Class I recall.
- This deviceK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990
- Descendant · cites it directly · 65 of its ownK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- Descendant · 2 generations on · 49 of its ownK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- Descendant · 3 generations on · 28 of its ownK042121 Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Recalled (Class I)
- Descendant · 4 generations on · 18 of its ownK133801 Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 16 of its ownK023189 Vista Basic with FM SystemB.Braun Medical, Inc. · 2003
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
1997high 7 (2014) · low 0 (1998)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 67 · See all- K994375Horizon LightB.Braun Medical, Inc. · 2000 · cites it directly65descendants
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 2 generations on49descendants
- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · 3 generations on28descendants
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 4 generations on18descendants
- K023189Vista Basic with FM SystemB.Braun Medical, Inc. · 2003 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | — |
| +1 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| +2 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| +3 | K042121 | Spectrum and Spectrum with Master Drug Library | Sigma Intl. | 2004 | Class I |
| +4 | K133801 | Baxter Sigma Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2014 | Class I |
| +2 | K023189 | Vista Basic with FM System | B.Braun Medical, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 1 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (67)
See all 672 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 |
|---|---|---|---|---|
| Aug 10, 2021 | Class II | Z-2552-2021 | Under Investigation by firm | Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections. |
| Aug 5, 2013 | Class II | Z-2166-2013 | Process control | Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection sites and corresponding low pressure backcheck valve… |
| Nov 24, 2009 | Not classified | Z-0675-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0676-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0691-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0697-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0698-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0703-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0679-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0680-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0690-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0694-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0709-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0710-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0712-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0713-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0715-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0716-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0717-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0681-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0682-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0683-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0687-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0688-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0689-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0692-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0693-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0711-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0714-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Mar 27, 2009 | Not classified | Z-1428-2009 | Mixed-up of materials/components | Device defect is occlusion/no flow. |
| Mar 27, 2009 | Not classified | Z-1431-2009 | Mixed-up of materials/components | Device defect is occlusion/no flow. |
| Jun 30, 2008 | Not classified | Z-2408-2008 | Mixed-up of materials/components | incorrect burette was packaged with the product |
| Jun 30, 2008 | Not classified | Z-2409-2008 | Mixed-up of materials/components | incorrect burette was packaged with the product |
| Jun 30, 2008 | Not classified | Z-2410-2008 | Mixed-up of materials/components | incorrect burette was packaged with the product |
| Jun 30, 2008 | Not classified | Z-2407-2008 | Mixed-up of materials/components | incorrect burette was packaged with the product |
| Apr 18, 2007 | Not classified | Z-0818-2007 | Other | Secondary infusion backs up into primary container. |
| Apr 18, 2007 | Not classified | Z-0819-2007 | Other | Secondary infusion backs up into primary container. |
The 5 latest of 37 recalls; the web page lists all.
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 · Cites it directly · ◆ in the 2000 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
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 2 generations on · ◆ in the 2001 descendants bar of FIG. 11 Class I recall
- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · 3 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 · 3 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- 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
- K191910SpaceStation MRIB. Braun Melsugen AG · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
- K121613Agilia Infusion SystemFresenius Kabi AG · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 15 Class I recalls
- K142596Infusomat Space Volumetric Infusion PumpB.Braun Medical, Inc. · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
- K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
Nearest 12 of 17 shown.
Nearest 5 of 17; all are on the web page.
What does this lineage say?
- Of its descendants, K994375 (B.Braun Medical, Inc., 2000) has gone furthest, with 65 descendants of its own.
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
2007high 12 (2007) · low 1 (2020)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
2007high 312 (2013) · low 66 (2009)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
2007high 102 (2009) · low 1 (2018)2026
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
2007high 888,020 (2022) · low 1,086 (2007)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) | — |
https://510kreport.com/device/K904518 · printed Nov 4, 2026
Cite this page
510(k) Report. “K904518: Volumetric Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904518
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026