510(k) · Cleared
Recalled · Class II · 2025LifeShield Infusion Safety Software Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · PHC Infusion Safety Management Software
Cleared on Apr 2, 2025 as substantially equivalent to K223606 (Icu Medical, Inc., 2023) after a 257-day review. Its family tree reaches back 6 generations to 1990. 4 of the 15 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Apr 2, 2025
- Review
- 257 days
- Class
- Class II
- Product code
- PHC
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K904518 (1990). 13 ancestors in all. 1 later device descends from it, 1 citing it directly. 4 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 5 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 4 generations backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- 3 generations backK042609 Hospira Mednet Medication Management SuiteHospira, Inc. · 2004 · Recalled
- 2 generations backK141102 Hospira Mednet Medication Management SuiteHospira, Inc. · 2014 · Recalled
- 1 generation backK223606 LifeShield™ Infusion Safety Software SuiteIcu Medical, Inc. · 2023 · Recalled
- This deviceK242117 LifeShield Infusion Safety Software SuiteIcu Medical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK252130 LifeShield Infusion Safety Software SuiteIcu Medical, Inc. · 2026
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K252130LifeShield Infusion Safety Software SuiteIcu Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −5 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −4 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| −3 | K042609 | Hospira Mednet Medication Management Suite | Hospira, Inc. | 2004 | 1 |
| −2 | K141102 | Hospira Mednet Medication Management Suite | Hospira, Inc. | 2014 | 2 |
| −1 | K223606 | LifeShield™ Infusion Safety Software Suite | Icu Medical, Inc. | 2023 | 1 |
| 0 (this device) | K242117 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | 2025 | — |
| +1 | 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 |
|---|---|---|
| 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 PHC device
- #1 K252130 LifeShield Infusion Safety Software Suitescore 12.9 · 7 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 |
|---|---|---|---|
| * | K223606 | LifeShield™ Infusion Safety Software SuiteSummary page 5…lation 21 CFR 880.5725 Panel General Hospital Product Code(s) PHC Predicate Device K223606, LifeShield™ Infusion Safety Software Suite The submission is a traditional pre-market notifi… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252130 | LifeShield Infusion Safety Software Suite | 2026 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 24, 2025 | Class II | Z-0965-2026 | Software Design Change | For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over… |
| Nov 24, 2025 | Class II | Z-0966-2026 | Software Design Change | Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change… |
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 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 14 Class I recalls
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · 6 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 4 companies; a new generation was cleared every 9.1 years on median.
- 10 of the 13 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K252130 (Icu Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PHC devicesPHC Infusion Safety Management Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PHC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHC
Too few PHC 510(k)s in any year since 2007 to give a median.
Recalls per year · PHC
2in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · PHC
18in 2025
MAUDE reports naming product code PHC, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 1 | 1 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 35 |
| 2022 | 2 | — | 1 (1) | 4 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 1 | — | 0 | 11 |
| 2025 | 2 | — | 2 | 18 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The LifeShield™ Infusion Safety Software Suite is a collection of software products that facilitates networked communication between compatible systems. The Infusion Safety Software Suite provides trained healthcare professionals the ability to manage data for compatible infusion pumps. All data entry and validation of infusion parameters on compatible infusion pumps is performed by a trained healthcare professional. LifeShield™ Infusion Safety Software…
Read the full statement (286 words)
The LifeShield™ Infusion Safety Software Suite is a collection of software products that facilitates networked communication between compatible systems. The Infusion Safety Software Suite provides trained healthcare professionals the ability to manage data for compatible infusion pumps. All data entry and validation of infusion parameters on compatible infusion pumps is performed by a trained healthcare professional. LifeShield™ Infusion Safety Software Suite is indicated for use in patients including adult, pediatric and neonate undergoing infusion therapy with connected compatible infusion pumps (as per the indications for use specified for the compatible infusion pump).
The LifeShield™ Drug Library Management (DLM) software product is intended to be used by pharmacists to create, configure, edit, and manage drug library data, including infusion pump settings, for use with compatible infusion pumps. Drug library contents are constructed based on the healthcare provider's defined best practices.
The LifeShield™ Clinical Dashboards & Reports (CDR) software product provides trained healthcare professionals with the capability to view and manage infusion information collected from compatible infusion pumps. Healthcare professionals may choose to use the collected infusion information to support continuous quality improvement programs, or to analyze and trend various aspects of the infusion pumps and therapies used. It is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.
The LifeShield™ Data Flow Management (DFM) software product is intended to facilitate bi-directional communication with compatible infusion pumps, information technology systems, and other LifeShield™ Infusion Safety Software Suite products. LifeShield™ DFM provides a way to automate the programming of infusion parameters, thereby decreasing the number of manual steps necessary to enter infusion data. LifeShield™ DFM forwards infusion-related information received from the infusion pump to compatible information technology systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242117 · printed Nov 4, 2026
Cite this page
510(k) Report. “K242117: LifeShield Infusion Safety Software Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K242117
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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