510(k) · Cleared
Recalled · Class II · 2017Medley Pca Module, Model 8120
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alaris Medical Systems, Inc. · MEA Pump, Infusion, Pca
Cleared on Sep 9, 2003 after a 50-day review. The FDA summary names no predicate by number. 4 of the 9 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 9, 2003
- Review
- 50 days
- Class
- Class II
- Product code
- MEA
- Recalls
- 3
- Predicates
- 0
8 later devices descend from it, 3 citing it directly. 4 of the 9 devices in this family, counting this one, have a Class I recall.
- This deviceK032233 Medley Pca Module, Model 8120Alaris Medical Systems, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK083689 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK121613 Agilia Infusion SystemFresenius Kabi AG · 2013 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK092313 Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 0 of its ownK210075 Vigilant Software Suite – Vigilant Master MedFresenius Kabi AG · 2022
- Descendant · 3 generations on · 0 of its ownK210073 Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat…Fresenius Kabi AG · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · cites it directly4descendants
- K121613Agilia Infusion SystemFresenius Kabi AG · 2013 · 2 generations on2descendants
- K092313Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 2009 · cites it directly1descendant
- K210075Vigilant Software Suite – Vigilant Master MedFresenius Kabi AG · 2022 · 3 generations on0descendants
- K210073Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration…Fresenius Kabi AG · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032233 | Medley Pca Module, Model 8120 | Alaris Medical Systems, Inc. | 2003 | — |
| +1 | K083689 | Infusomat Space Volumetric Infusion Pump System | B.Braun Medical, Inc. | 2009 | Class I |
| +2 | K121613 | Agilia Infusion System | Fresenius Kabi AG | 2013 | Class I |
| +1 | K092313 | Perfusor Space Infusion Syringe Pump System | B.Braun Medical, Inc. | 2009 | 4 |
| +3 | K210075 | Vigilant Software Suite – Vigilant Master Med | Fresenius Kabi AG | 2022 | — |
| +3 | K210073 | Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines… | Fresenius Kabi AG | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 1 |
| 2009 | 2 | 1 |
| 2013 | 1 | 1 |
| 2015 | 1 | 1 |
| 2018 | 1 | 0 |
| 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.
4 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 17, 2017 | Class II | Z-0323-2018 | Nonconforming Material/Component | The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed. |
| Jun 12, 2009 | Not classified | Z-1794-2009 | Device Design | There is a potential risk of IUI connector failure in the Alaris System when these connectors become corroded or contaminated, which may result in an interruption of infusion with an audible and visual alarm. IUI connectors can become… |
| Mar 4, 2009 | Not classified | Z-1237-2009 | Software design | The Alaris PCA module can potentially infuse above or below the intended infusion dose. |
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.
- K043299Medley Pca Module, Model 8120Alaris 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
- 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
What does this lineage say?
- Of its descendants, K083689 (B.Braun Medical, Inc., 2009) has gone furthest, with 4 descendants of its own.
How does its category compare?
All MEA devicesMEA Pump, Infusion, Pca: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEA
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MEA
Too few MEA 510(k)s in any year since 2007 to give a median.
Recalls per year · MEA
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEA
3,278in 2025
MAUDE reports naming product code MEA, 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 | 81 |
| 2008 | 1 | — | 1 | 237 |
| 2009 | 1 | — | 0 | 153 |
| 2010 | 0 | — | 4 | 219 |
| 2011 | 0 | — | 2 | 245 |
| 2012 | 0 | — | 0 | 446 |
| 2013 | 1 | — | 0 | 453 |
| 2014 | 0 | — | 1 | 382 |
| 2015 | 0 | — | 0 | 99 |
| 2016 | 1 | — | 0 | 57 |
| 2017 | 2 | — | 2 | 44 |
| 2018 | 0 | — | 0 | 256 |
| 2019 | 0 | — | 0 | 132 |
| 2020 | 0 | — | 0 | 2,331 |
| 2021 | 0 | — | 0 | 3,776 |
| 2022 | 0 | — | 1 | 6,443 |
| 2023 | 0 | — | 0 | 3,984 |
| 2024 | 0 | — | 1 | 4,559 |
| 2025 | 0 | — | 0 | 3,278 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of medications or fluids.
The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), subcutaneous, or epidural.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032233 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032233: Medley Pca Module, Model 8120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032233
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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