510(k) · Cleared
ClearedVigilant Software Suite – Vigilant Master Med
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Kabi AG · PHC Infusion Safety Management Software
Cleared on Mar 1, 2022 as substantially equivalent to K121613 (Fresenius Kabi AG, 2013) after a 413-day review. Its family tree reaches back 6 generations to 1990. 6 of the 24 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 1, 2022
- Review
- 413 days
- Class
- Class II
- Product code
- PHC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K904518 (1990). 23 ancestors in all, the oldest K820133 (1982). No later device cites it as a predicate yet. 6 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 5 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 4 generations backK023189 Vista Basic with FM SystemB.Braun Medical, Inc. · 2003
- 3 generations backK062700 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · Recalled (Class I)
- 2 generations backK083689 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · Recalled (Class I)
- 1 generation backK121613 Agilia Infusion SystemFresenius Kabi AG · 2013 · Recalled (Class I)
- This deviceK210075 Vigilant Software Suite – Vigilant Master MedFresenius Kabi AG · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −5 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −4 | K023189 | Vista Basic with FM System | B.Braun Medical, Inc. | 2003 | — |
| −3 | K062700 | Infusomat Space Volumetric Infusion Pump System | B.Braun Medical, Inc. | 2006 | Class I |
| −2 | K083689 | Infusomat Space Volumetric Infusion Pump System | B.Braun Medical, Inc. | 2009 | Class I |
| −1 | K121613 | Agilia Infusion System | Fresenius Kabi AG | 2013 | Class I |
| 0 (this device) | K210075 | Vigilant Software Suite – Vigilant Master Med | Fresenius Kabi AG | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 2 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 1 |
| 1997 | 1 | 0 |
| 2001 | 1 | 1 |
| 2003 | 2 | 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.
6 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 PHC device
- #1 K252130 LifeShield Infusion Safety Software Suitescore 12.9 · 7 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 |
|---|---|---|---|
| * | K121613 | Agilia Infusion SystemSummary page 5…www.fresenius-kabi.us Legally Marketed Predicate Device Vigilant Drug’ Lib Agilia that was cleared as an accessory to K121613 Agilia Infusion System Device Description Vigilant Master Med is one component of Vigilant Software Suite (VSS) a multifunction… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
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.
- K121613Agilia Infusion SystemFresenius Kabi AG · 2013 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 3 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
- K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · 3 generations back · ◆ in the 1995 ancestors bar of FIG. 14 Class I recalls
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 14 of the 23 ancestors have a recall of any class; 6 have a Class I recall.
- 1 other device also cites its predicate K121613.
How does its category compare?
All PHC devicesPHC Infusion Safety Management Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PHC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHC
Too few PHC 510(k)s in any year since 2007 to give a median.
Recalls per year · PHC
2in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · PHC
18in 2025
MAUDE reports naming product code PHC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 1 | 1 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 35 |
| 2022 | 2 | — | 1 (1) | 4 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 1 | — | 0 | 11 |
| 2025 | 2 | — | 2 | 18 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Vigilant Master Med is part of a Dose Error Reduction System (DERS) for use with Adults, Pediatrics, and Neonates. It is intended to create, customize, and manage drug library data and device configurations to be uploaded to compatible Fresenius Kabi infusion devices which may reduce the risk of drug administration errors. It enhances safety by preventing infusion errors with the use of Dose Error Reduction System (DERS) in combination with the infusion…
Read the full statement (134 words)
Vigilant Master Med is part of a Dose Error Reduction System (DERS) for use with Adults, Pediatrics, and Neonates. It is intended to create, customize, and manage drug library data and device configurations to be uploaded to compatible Fresenius Kabi infusion devices which may reduce the risk of drug administration errors. It enhances safety by preventing infusion errors with the use of Dose Error Reduction System (DERS) in combination with the infusion devices.
Vigilant Master Med is a drug library software that is used by pharmacists to create and identify limits according to policy and procedure of the institution. The infusion devices will notify and clearly indicate to a clinician if the dose for the medication is beyond the limits entered by the pharmacist and provided by Vigilant Master Med in the drug library.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210075 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210075: Vigilant Software Suite – Vigilant Master Med.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210075
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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