510(k) · Cleared
ClearedDose IQ Safety Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corporation · PHC Infusion Safety Management Software
Cleared on Aug 30, 2022 as substantially equivalent to K173084 (Baxter Healthcare Corporation, 2018) after a 502-day review. Its family tree reaches back 6 generations to 1990. 5 of the 11 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 30, 2022
- Review
- 502 days
- Class
- Class II
- Product code
- PHC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K904518 (1990). 10 ancestors in all. No later device cites it as a predicate yet. 5 of the 11 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 backK042121 Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Recalled (Class I)
- 2 generations backK133801 Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · Recalled (Class I)
- 1 generation backK173084 Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · Recalled (Class I)
- This deviceK211124 Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2022
Class I recalls in this family
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 | 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 | K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software | Baxter Healthcare Corporation | 2018 | Class I |
| 0 (this device) | K211124 | Dose IQ Safety Software | Baxter Healthcare Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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.
5 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 |
|---|---|---|---|
| * | K173084 | Spectrum IQ Infusion System, Dose IQ Safety SoftwareSummary page 5…Device Company Predicate 510(k) Clearance Date Spectrum IQ Infusion System Baxter Healthcare K173084 May 11, 2018 with Dose IQ Safety Software1 Corporation DESCRIPTION OF THE DEVICE: Dose IQ is a standalo… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 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.
- K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 2 generations back · ◆ on the line of descent in FIG. 15 Class I recalls
- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · 3 generations back · ◆ on the line of descent in FIG. 13 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
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 7 of the 10 ancestors have a recall of any class; 5 have a Class I recall.
- 4 other devices also cite its predicate K173084.
How does its category compare?
All PHC devicesPHC Infusion Safety Management Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Dose IQ Safety Software is intended to be used with the Novum IQ Syringe Pump to support the controlled administration of fluids.
Dose IQ Safety Software is intended to allow users to create and maintain drug libraries, including the configuration of pump settings for the Novum IQ Syringe Pump.
Dose IQ Safety Software is intended to allow users to establish the facility-defined syringe list, which is a subset of Baxter’s approved compatible syringes, for the Novum IQ Syringe Pump.
Dose IQ Safety Software is intended to be used by licensed pharmacists.
Dose IQ Safety Software is intended to be used in hospitals and outpatient health care facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211124: Dose IQ Safety Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211124
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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