510(k) · Cleared
Recalled · Class I · 2021Spectrum IQ Infusion System, Dose IQ Safety Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corporation · FRN Pump, Infusion
Cleared on May 11, 2018 as substantially equivalent to K133801 (Baxter Healthcare Corporation, 2014) after a 224-day review. Its family tree reaches back 5 generations to 1990. 8 of the 19 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it. It has been recalled 8 times, including 4 Class I recalls.
- Decided
- May 11, 2018
- Review
- 224 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 8 (4 Class I)
- Predicates
- 1
Its longest line of descent runs back 5 generations to K904518 (1990). 9 ancestors in all. 9 later devices descend from it, 5 citing it directly. 8 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 4 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 3 generations backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- 2 generations backK042121 Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Recalled (Class I)
- 1 generation backK133801 Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · Recalled (Class I)
- This deviceK173084 Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018
- Descendant · cites it directly · 3 of its ownK220417 Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2022
- Descendant · 2 generations on · 2 of its ownK222048 Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2022
- Descendant · 3 generations on · 1 of its ownK230041 Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2023 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK183311 Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · Recalled (Class I)
- Descendant · 4 generations on · 0 of its ownK251636 Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation · 2025 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K220417Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2022 · cites it directly3descendants
- K222048Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2022 · 2 generations on2descendants
- K230041Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2023 · 3 generations on1descendant
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · cites it directly1descendant
- K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −4 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −3 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| −2 | K042121 | Spectrum and Spectrum with Master Drug Library | Sigma Intl. | 2004 | Class I |
| −1 | K133801 | Baxter Sigma Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2014 | Class I |
| 0 (this device) | K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software | Baxter Healthcare Corporation | 2018 | — |
| +1 | K220417 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | 2022 | — |
| +2 | K222048 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | 2022 | — |
| +3 | K230041 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | 2023 | Class I |
| +1 | K183311 | Ivenix Infusion System (IIS) | Ivenix, Inc. | 2019 | Class I |
| +4 | K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) | Baxter Healthcare Corporation | 2025 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 1 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 1 |
| 2024 | 2 | 1 |
| 2025 | 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.
8 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 |
|---|---|---|---|
| * | K133801 | Baxter Sigma Spectrum Infusion Pump with Master Drug LibrarySummary page 5…ble 2. Predicate Device Device Company Predicate 510(k) Clearance Date Baxter SIGMA Baxter Healthcare K133801 May 7, 2014 Spectrum Infusion Corporation Pump with Master Drug Library DESCRIPTION OF THE DEV… | 2014 |
What descends from it? (9)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (8 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 29, 2021 | Class I | Z-0529-2022 | Device Design | There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion… |
| Jul 7, 2021 | Class I | Z-2165-2021 | Software design | Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump. |
| Jun 4, 2021 | Class I | Z-2110-2021 | Software design | System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors. |
| Mar 19, 2021 | Class II | Z-1487-2021 | Device Design | Potentially defective component in the AC power adapter which may fail over time. |
| Jan 6, 2021 | Class II | Z-1150-2021 | Under Investigation by firm | Battery performance issues related to prolonged storage. |
| Nov 23, 2020 | Class II | Z-0715-2021 | Under Investigation by firm | There is a potential software error during programming. |
| Jun 30, 2020 | Class I | Z-0123-2021 | Labeling design | Baxter is updating the device IFU for safety communication regarding cleaning practices. |
| Sep 18, 2018 | Class II | Z-0107-2019 | Software design | If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from… |
The 5 latest of 8 recalls; the web page lists all.
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.
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · Direct predicate · ◆ on the line of descent in FIG. 15 Class I recalls
- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls
- K211122Novum IQ Large Volume PumpBaxter Healthcare Corporation · 2024 · Cites it directly · ◆ in the 2024 descendants bar of FIG. 13 Class I recalls
- K230041Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 6 of the 9 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K220417 (Baxter Healthcare Corporation, 2022) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K133801.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, and blood products. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, or epidural. The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used in conjunction with legally marketed…
Read the full statement (170 words)
The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, and blood products. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, or epidural. The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.
The Spectrum IQ Infusion System with Dose IQ Safety Software is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas.
The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to reduce operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies. This automation is intended to reduce pump programming errors.
The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used by trained healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173084: Spectrum IQ Infusion System, 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/K173084
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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