510(k) · Cleared
Recalled · Class I · 2019Agilia Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Kabi AG · FRN Pump, Infusion
Cleared on May 1, 2013 as substantially equivalent to K062700 (B.Braun Medical, Inc., 2006) and 1 other predicate after a 334-day review. Its family tree reaches back 5 generations to 1990. 6 of the 25 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- May 1, 2013
- Review
- 334 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 2 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 5 generations to K904518 (1990). 22 ancestors in all, the oldest K820133 (1982). 2 later devices descend from it, 2 citing it directly. 6 of the 25 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 4 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 3 generations backK023189 Vista Basic with FM SystemB.Braun Medical, Inc. · 2003
- 2 generations backK062700 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · Recalled (Class I)
- 1 generation backK083689 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · Recalled (Class I)
- This deviceK121613 Agilia Infusion SystemFresenius Kabi AG · 2013
- Descendant · cites it directly · 0 of its ownK210075 Vigilant Software Suite – Vigilant Master MedFresenius Kabi AG · 2022
- Descendant · cites it directly · 0 of its ownK210073 Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat…Fresenius Kabi AG · 2022
Class I recalls in this family
- K083689 Infusomat Space Volumetric Infusion Pump Systemdirect predicate · 2009
- K062700 Infusomat Space Volumetric Infusion Pump Systemdirect predicate · 2006
- K011975 Horizon Outlook with Dosecom2 generations back · 2001
- K950419 The Imed Orion Infusion Pump and Administration…2 generations back · 1995
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −4 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −3 | 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 |
| −1 | K083689 | Infusomat Space Volumetric Infusion Pump System | B.Braun Medical, Inc. | 2009 | Class I |
| 0 (this device) | K121613 | Agilia Infusion System | Fresenius Kabi AG | 2013 | — |
| +1 | K210075 | Vigilant Software Suite – Vigilant Master Med | Fresenius Kabi AG | 2022 | — |
| +1 | K210073 | Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines… | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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 |
|---|---|---|---|
| * | K062700 | Infusomat Space Volumetric Infusion Pump SystemSummary page 1…system Classification Name: Infusion pumps Intravascular administration sets 3. PREDICATE DEVICES K062700/K083689 B. Braun.Medical, Inc., Infusomat® Space Volumetric Infusion Pump System 4. DEVICE DESCRIPTION The… | 2006 |
| * | K083689 | Infusomat Space Volumetric Infusion Pump SystemSummary page 1…Classification Name: Infusion pumps Intravascular administration sets 3. PREDICATE DEVICES K062700/K083689 B. Braun.Medical, Inc., Infusomat® Space Volumetric Infusion Pump System 4. DEVICE DESCRIPTION The Agilia… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2019 | Class I | Z-2064-2019 | Other | The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib |
| Dec 2, 2017 | Class II | Z-0362-2019 | Software design | Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusion Pump because it was designed to improve customer experience while preventing common software malfunctions. |
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.
- K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 2 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
- K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · 2 generations back · ◆ in the 1995 ancestors bar of FIG. 14 Class I recalls
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 13 of the 22 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K210075 (Fresenius Kabi AG, 2022) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K062700.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 Agilia Infusion System is a transportable equipment intended to be used in
healthcare facilities environment by healthcare trained professionals according to
hospital protocols on adults, pediatrics and neonates human patients to administer via a
single channel or mounted on a multiple channels rack accessory:
-Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral
nutrition) and medications (including but not limited to diluted drugs, chemotherapy)
through clinically accepted IV routes of administration.
- Transfusion of blood and blood derivatives products. Note that for transfusion
procedures, use of a special administration set is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121613: Agilia Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121613
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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