510(k) · Cleared
ClearedMedley System with Medication Management System (MMS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alaris Medical Systems, Inc. · FRN Pump, Infusion
Cleared on Apr 4, 2003 after a 52-day review. The FDA summary names its predicate without a number. 21 of the 74 devices in its family, counting itself, have a Class I recall. 73 later devices descend from it.
- Decided
- Apr 4, 2003
- Review
- 52 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 0
73 later devices descend from it, 9 citing it directly. 21 of the 74 devices in this family, counting this one, have a Class I recall.
- This deviceK030459 Medley System with Medication Management System (MMS)Alaris Medical Systems, Inc. · 2003
- Descendant · cites it directly · 28 of its ownK042121 Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Recalled (Class I)
- Descendant · 2 generations on · 18 of its ownK133801 Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · Recalled (Class I)
- Descendant · cites it directly · 15 of its ownK062700 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · Recalled (Class I)
- Descendant · 3 generations on · 9 of its ownK173084 Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · Recalled (Class I)
- Descendant · 2 generations on · 7 of its ownK123049 Sapphire Infusion PumpQ Core Medical, Ltd. · 2013
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K062700 Infusomat Space Volumetric Infusion Pump Systemcites it directly · 2006
- K042121 Spectrum and Spectrum with Master Drug Librarycites it directly · 2004
- K041241 Medley System with Bar Code Module, Model 8600cites it directly · 2004
- K072105 Alaris System with MMS, Model 8XXXcites it directly · 2007
Most influential descendants
Showing 5 of 73 · See all- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · cites it directly28descendants
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 2 generations on18descendants
- K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · cites it directly15descendants
- K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · 3 generations on9descendants
- K123049Sapphire Infusion PumpQ Core Medical, Ltd. · 2013 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030459 | Medley System with Medication Management System (MMS) | Alaris Medical Systems, Inc. | 2003 | — |
| +1 | K042121 | Spectrum and Spectrum with Master Drug Library | Sigma Intl. | 2004 | Class I |
| +2 | K133801 | Baxter Sigma Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2014 | Class I |
| +1 | K062700 | Infusomat Space Volumetric Infusion Pump System | B.Braun Medical, Inc. | 2006 | Class I |
| +3 | K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software | Baxter Healthcare Corporation | 2018 | Class I |
| +2 | K123049 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 2 |
| 2005 | 2 | 0 |
| 2006 | 2 | 1 |
| 2007 | 2 | 1 |
| 2009 | 3 | 1 |
| 2011 | 2 | 1 |
| 2012 | 1 | 0 |
| 2013 | 2 | 1 |
| 2014 | 8 | 3 |
| 2015 | 2 | 1 |
| 2016 | 6 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 1 |
| 2019 | 2 | 1 |
| 2020 | 5 | 2 |
| 2021 | 2 | 0 |
| 2022 | 9 | 1 |
| 2023 | 5 | 3 |
| 2024 | 4 | 2 |
| 2025 | 7 | 0 |
| 2026 | 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.
21 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 |
|---|---|---|---|
| * | — | Horizon Outlook with DoseCom Named without a submission number |
What descends from it? (73)
See all 739 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042121 | Spectrum and Spectrum with Master Drug Library Class I | 2004 | 28 |
| K062700 | Infusomat Space Volumetric Infusion Pump System Class I | 2006 | 15 |
| K041241 | Medley System with Bar Code Module, Model 8600 Class I | 2004 | 7 |
| K111386 | Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety… Class I | 2011 | 4 |
| K072105 | Alaris System with MMS, Model 8XXX Class I | 2007 | 4 |
| K062699 | Perfusor Space Infusion Syringe Pump System | 2006 | 4 |
| K042609 | Hospira Mednet Medication Management Suite | 2004 | 4 |
| K133532 | Alaris System with Guardrails Suite MX Class I | 2014 | 3 |
| K043590 | SE Infusion System with MMS | 2005 | 0 |
Has anything in its family been recalled? (21 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.
- K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 13 Class I recalls
- K041241Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K072105Alaris System with MMS, Model 8XXXCardinal Health 303,Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 13 Class I recalls
- K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 128 Class I recalls
- K111386Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported…Smiths Medical MD, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 16 Class I recalls
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 15 Class I recalls
- K191910SpaceStation MRIB. Braun Melsugen AG · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
- K142036Infusomat Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc. · 2014 · 2 generations on · ◆ in the 2014 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
- K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K211125Novum IQ Syringe PumpBaxter Healthcare Corporation · 2022 · 2 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
Nearest 12 of 21 shown.
Nearest 5 of 21; all are on the web page.
What does this lineage say?
- Of its descendants, K042121 (Sigma Intl., 2004) has gone furthest, with 28 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
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 ALARIS Medical Systems, Inc., Medley™ System with Medication Management System (MMS) is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products.
The Medley™ System with MMS is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030459: Medley System with Medication Management System (MMS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030459
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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