510(k) · Cleared
Recalled · Class I · 2025Baxter Sigma Spectrum Infusion Pump with Master Drug Library
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 7, 2014 as substantially equivalent to K042121 (Sigma Intl., 2004) after a 145-day review. Its family tree reaches back 4 generations to 1990. 9 of the 27 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it. It has been recalled 15 times, including 5 Class I recalls.
- Decided
- May 7, 2014
- Review
- 145 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 15 (5 Class I)
- Predicates
- 1
Its longest line of descent runs back 4 generations to K904518 (1990). 8 ancestors in all. 18 later devices descend from it, 3 citing it directly. 9 of the 27 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 backK042121 Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Recalled (Class I)
- This deviceK133801 Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014
- Descendant · cites it directly · 9 of its ownK173084 Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · Recalled (Class I)
- Descendant · cites it directly · 5 of its ownK142374 ivWatch Model 400Ivwatch, LLC · 2015
- Descendant · 2 generations on · 4 of its ownK153605 ivWatch Model 400Ivwatch, LLC · 2016
- Descendant · 2 generations on · 3 of its ownK220417 Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2022
- Descendant · 3 generations on · 3 of its ownK162478 ivWatchIvwatch, LLC · 2016
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 18 · See all- K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · cites it directly9descendants
- K142374ivWatch Model 400Ivwatch, LLC · 2015 · cites it directly5descendants
- K153605ivWatch Model 400Ivwatch, LLC · 2016 · 2 generations on4descendants
- K220417Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2022 · 2 generations on3descendants
- K162478ivWatchIvwatch, LLC · 2016 · 3 generations on3descendants
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 | K042121 | Spectrum and Spectrum with Master Drug Library | Sigma Intl. | 2004 | Class I |
| 0 (this device) | K133801 | Baxter Sigma Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2014 | — |
| +1 | K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software | Baxter Healthcare Corporation | 2018 | Class I |
| +1 | K142374 | ivWatch Model 400 | Ivwatch, LLC | 2015 | — |
| +2 | K153605 | ivWatch Model 400 | Ivwatch, LLC | 2016 | — |
| +2 | K220417 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | 2022 | — |
| +3 | K162478 | ivWatch | Ivwatch, LLC | 2016 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 1 |
| 2019 | 1 | 1 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 2 |
| 2024 | 3 | 1 |
| 2025 | 2 | 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.
9 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 |
|---|---|---|---|
| * | K042121 | Spectrum and Spectrum with Master Drug LibrarySummary page 1…device: -SIGMA Spectrum and Spectrum with Master Drug Library. cleared Aug. 26, 2004 (K042121). Device Description: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is a la… | 2004 |
What descends from it? (18)
See all 183 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (9 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 20, 2025 | Class I | Z-2095-2025 | Employee error | Certain Spectrum infusion pumps may have an incorrect version of software. |
| Feb 5, 2025 | Class I | Z-1253-2025 | Under Investigation by firm | There is the potential for missing motor mounting screws, which may have occurred during the servicing process. |
| Nov 19, 2024 | Class II | Z-0775-2025 | Process control | Devices were identified as released after repair without full testing being performed, which includes flow testing. |
| Dec 29, 2021 | Class I | Z-0530-2022 | 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… |
| 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-0714-2021 | Under Investigation by firm | There is a potential software error during programming. |
| Jun 30, 2020 | Class I | Z-0121-2021 | Labeling design | Baxter is updating the device IFU for safety communication regarding cleaning practices. |
| Jun 30, 2020 | Class I | Z-0122-2021 | Labeling design | Baxter is updating the device IFU for safety communication regarding cleaning practices. |
| Jun 21, 2018 | Class II | Z-1248-2019 | Process control | The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time. Improperly performed flow rate testing may not… |
| May 8, 2018 | Class II | Z-2113-2018 | Other | The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a secondary infusion. However, the firm supplies… |
| Oct 6, 2017 | Class II | Z-0971-2018 | Nonconforming Material/Component | Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion. |
| Jan 26, 2017 | Class II | Z-1693-2017 | Process design | SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Specifically, the software anomaly causes the error message only under conditions in… |
| Sep 28, 2016 | Class II | Z-0671-2017 | Process control | A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely. |
| Sep 28, 2016 | Class II | Z-0672-2017 | Process control | A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Case Assembly in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential… |
| Mar 2, 2015 | Class II | Z-1451-2015 | Under Investigation by firm | Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the nearest integer in minutes on the pump dose setup screen (20… |
The 5 latest of 15 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.
- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Direct predicate · ◆ on the line of descent in FIG. 13 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
- K230022Baxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2023 · Cites it directly · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
- K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · Cites it directly · ◆ in the 2018 descendants bar of FIG. 14 Class I recalls
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls
- K211122Novum IQ Large Volume PumpBaxter Healthcare Corporation · 2024 · 2 generations on · ◆ in the 2024 descendants bar of FIG. 13 Class I recalls
- K230041Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 9.4 years on median.
- 5 of the 8 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K173084 (Baxter Healthcare Corporation, 2018) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K042121.
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 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically accepted routes; intravenous, arterial, subcutaneous, epidural or irrigation of fluid space. The Baxter SIGMA Spectrum Infusion Pump with Master…
Read the full statement (160 words)
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically accepted routes; intravenous, arterial, subcutaneous, epidural or irrigation of fluid space. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is suitable for a variety of patient care environments such as, but not limited to hospitals and outpatient care areas.
The Daxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to reduce operator interaction through guided programming, thereby helping to reduce errors. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used by trained healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133801: Baxter Sigma Spectrum Infusion Pump with Master Drug Library.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133801
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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