510(k) · Cleared
ClearedAgilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable
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 Mar 1, 2022 as substantially equivalent to K133532 (Carefusion 303, Inc., 2014) after a 413-day review. Its family tree reaches back 4 generations to 1994. 6 of the 18 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 1, 2022
- Review
- 413 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K940147 (1994). 17 ancestors in all, the oldest K890120 (1989). No later device cites it as a predicate yet. 6 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK940147 Auto Syringe AS40A Infusion PumpBaxter Corp. · 1994 · Recalled
- 3 generations backK974332 Variable Pressure Syringe PumpAlaris Medical Systems, Inc. · 1998
- 2 generations backK023264 Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · Recalled (Class I)
- 1 generation backK133532 Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · Recalled (Class I)
- This deviceK210074 Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia…Fresenius 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 |
|---|---|---|---|---|---|
| −4 | K940147 | Auto Syringe AS40A Infusion Pump | Baxter Corp. | 1994 | 1 |
| −3 | K974332 | Variable Pressure Syringe Pump | Alaris Medical Systems, Inc. | 1998 | — |
| −2 | K023264 | Medley Syringe Pump Module System, Model 8110 | Alaris Medical Systems, Inc. | 2002 | Class I |
| −1 | K133532 | Alaris System with Guardrails Suite MX | Carefusion 303, Inc. | 2014 | Class I |
| 0 (this device) | K210074 | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link… | Fresenius Kabi AG | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 2 | 1 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 1 |
| 2003 | 1 | 0 |
| 2005 | 1 | 1 |
| 2007 | 1 | 1 |
| 2009 | 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.
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? (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 |
|---|---|---|---|
| * | K133532 | Alaris System with Guardrails Suite MXSummary page 5…II Infusion pump accessories 80 MRZ Legally Marketed Device Under Which Substantial Equivalence is Being Claimed Alaris System with Guardrails Suite MX (K133532) Device Description The Agilia SP Infusion System includes the Agilia SP MC WiFi Syringe Infusion Pump which is a programmable… | 2014 |
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.
- K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · Direct predicate · ◆ on the line of descent in FIG. 128 Class I recalls
- K072105Alaris System with MMS, Model 8XXXCardinal Health 303,Inc. · 2007 · 2 generations back · ◆ in the 2007 ancestors bar of FIG. 13 Class I recalls
- K051641Alaris System PC Unit, Model 8001Cardinal Health, Alaris Products · 2005 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 110 Class I recalls
- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K012383Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii)…Alaris Medical Systems, Inc. · 2001 · 2 generations back · ◆ in the 2001 ancestors bar of FIG. 13 Class I recalls
- K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · 2 generations back · ◆ in the 1995 ancestors bar of FIG. 14 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- 11 of the 17 ancestors have a recall of any class; 6 have a Class I recall.
- 1 other device also cites its predicate K133532.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 SP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medication, blood, and blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, subcutaneous, and intraosseous using dedicated administration sets. The Agilia SP Infusion System is also intended for neonatal care for the…
Read the full statement (114 words)
The Agilia SP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medication, blood, and blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, subcutaneous, and intraosseous using dedicated administration sets.
The Agilia SP Infusion System is also intended for neonatal care for the intermittent or continuous delivery of parenteral fluids for hydration and nutrition, medication, blood, and blood derivatives through clinically accepted parenteral routes of administration and critical drugs under specific conditions. These routes of administration include intravenous, intra-arterial, and subcutaneous using dedicated administration sets.
It is intended for use by trained healthcare professionals in healthcare facilities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210074 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210074: Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210074
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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