510(k) · Cleared
Recalled · Class II · 2017Hospira 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 Jul 8, 2014 as substantially equivalent to K042609 (Hospira, Inc., 2004) after a 70-day review. Its family tree reaches back 4 generations to 1990. 4 of the 15 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 8, 2014
- Review
- 70 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K904518 (1990). 11 ancestors in all. 3 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 · 4 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 3 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 2 generations backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- 1 generation backK042609 Hospira Mednet Medication Management SuiteHospira, Inc. · 2004 · Recalled
- This deviceK141102 Hospira Mednet Medication Management SuiteHospira, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK223606 LifeShield™ Infusion Safety Software SuiteIcu Medical, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 1 of its ownK242117 LifeShield Infusion Safety Software SuiteIcu Medical, Inc. · 2025 · Recalled
- Descendant · 3 generations on · 0 of its ownK252130 LifeShield Infusion Safety Software SuiteIcu Medical, Inc. · 2026
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K223606LifeShield™ Infusion Safety Software SuiteIcu Medical, Inc. · 2023 · cites it directly2descendants
- K242117LifeShield Infusion Safety Software SuiteIcu Medical, Inc. · 2025 · 2 generations on1descendant
- K252130LifeShield Infusion Safety Software SuiteIcu Medical, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −3 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −2 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| −1 | K042609 | Hospira Mednet Medication Management Suite | Hospira, Inc. | 2004 | 1 |
| 0 (this device) | K141102 | Hospira Mednet Medication Management Suite | Hospira, Inc. | 2014 | — |
| +1 | K223606 | LifeShield™ Infusion Safety Software Suite | Icu Medical, Inc. | 2023 | 1 |
| +2 | K242117 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | 2025 | 2 |
| +3 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K042609 | Hospira Mednet Medication Management SuiteSummary page 1…725 Product Code(s) FRN Legally marketed Hospira MedNetm" Medication Management Suite (MMS), cleared device(s) to which under K042609. equivalence Is claimed Reason for 510(k) Software Changes submission Device description The Hospira M… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223606 | LifeShield™ Infusion Safety Software Suite | 2023 | 2 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 30, 2017 | Class II | Z-0195-2018 | Under Investigation by firm | Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) whether a medication may be piggybacked and (b)… |
| Jul 28, 2016 | Class II | Z-2790-2016 | Software design | Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million 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 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 14 Class I recalls
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · 4 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- 8 of the 11 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K223606 (Icu Medical, Inc., 2023) has gone furthest, with 2 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. 2014, 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 Hospira MedNet 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/K141102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141102: 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/K141102
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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