510(k) · Cleared
Recalled · Class II · 2014Hospira Mednet Medication Management Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · FRN Pump, Infusion
Cleared on Oct 6, 2004 as substantially equivalent to K042081 (Hospira, Inc., 2004) and 2 other predicates after a 12-day review. Its family tree reaches back 3 generations to 1990. 4 of the 15 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled once.
- Decided
- Oct 6, 2004
- Review
- 12 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K904518 (1990). 10 ancestors in all. 4 later devices descend from it, 1 citing it directly. 4 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 2 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 1 generation backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- This deviceK042609 Hospira Mednet Medication Management SuiteHospira, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK141102 Hospira Mednet Medication Management SuiteHospira, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 2 of its ownK223606 LifeShield™ Infusion Safety Software SuiteIcu Medical, Inc. · 2023 · Recalled
- Descendant · 3 generations on · 1 of its ownK242117 LifeShield Infusion Safety Software SuiteIcu Medical, Inc. · 2025 · Recalled
- Descendant · 4 generations on · 0 of its ownK252130 LifeShield Infusion Safety Software SuiteIcu Medical, Inc. · 2026
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K141102Hospira Mednet Medication Management SuiteHospira, Inc. · 2014 · cites it directly3descendants
- K223606LifeShield™ Infusion Safety Software SuiteIcu Medical, Inc. · 2023 · 2 generations on2descendants
- K242117LifeShield Infusion Safety Software SuiteIcu Medical, Inc. · 2025 · 3 generations on1descendant
- K252130LifeShield Infusion Safety Software SuiteIcu Medical, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −2 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −1 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| 0 (this device) | K042609 | Hospira Mednet Medication Management Suite | Hospira, Inc. | 2004 | — |
| +1 | K141102 | Hospira Mednet Medication Management Suite | Hospira, Inc. | 2014 | 2 |
| +2 | K223606 | LifeShield™ Infusion Safety Software Suite | Icu Medical, Inc. | 2023 | 1 |
| +3 | K242117 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | 2025 | 2 |
| +4 | K252130 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 1 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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.
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.
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? (3)
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 |
|---|---|---|---|
| * | K042081 | Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with…Summary page 1…21 CFR Parts 880.5725 3. Trade Name of Hospira MedNet TM Medication Management Suite Proposed Device: 5. Predicate Devices K 042081 Plum A+®/A+®3 Infusion Systems with Hospira MedNetPr Software… | 2004 |
| * | K030459 | Medley System with Medication Management System (MMS)Summary page 1…5. Predicate Devices K 042081 Plum A+®/A+®3 Infusion Systems with Hospira MedNetPr Software K030459 Medley TM with Medication Management System (Medley~ System MIMS)… | 2003 |
| * | K011975 | Horizon Outlook with DosecomSummary page 1…K030459 Medley TM with Medication Management System (Medley~ System MIMS) K01 1975 Horizon Outlook'TM with DoseComnT M 5. Proposed Device Description: The Hospira MedNetTm Medication Management Suit… | 2001 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141102 | Hospira Mednet Medication Management Suite | 2014 | 3 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 6, 2014 | Class II | Z-2027-2014 | Under Investigation by firm | Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg/min" and "milliUnits/min" are not sent to a Plum A+ device (Version 13.40, 13.41, and 13.4.2) via Auto Programming when those dosing units… |
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.
- K042081Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet…Hospira, Inc. · 2004 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 14 Class I recalls
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · 3 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 7 of the 10 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K141102 (Hospira, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K042081.
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 Hospira MedNet TM Medication Management Suite (MMS) is intended to facilitate
networked communication between MMS compatible computer systems and Hospira
infusion pumps. The MMS provides trained healthcare professionals with the
capability to send, receive, report, and store information from interfaced external
systems, and to configure and edit infusion programming parameters.
The MMS is intended to provide 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 a
trained healthcare professional according to physician's orders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042609: Hospira Mednet Medication Management Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042609
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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