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 Mar 31, 2023 as substantially equivalent to K133801 (Baxter Healthcare Corporation, 2014) after an 86-day review. Its family tree reaches back 5 generations to 1990. 5 of the 11 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 5 times, including 2 Class I recalls.
- Decided
- Mar 31, 2023
- Review
- 86 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 5 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 5 generations to K904518 (1990). 9 ancestors in all. 1 later device descends from it, 1 citing it directly. 5 of the 11 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 deviceK230022 Baxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2023
- Descendant · cites it directly · 0 of its ownK251640 SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2025 · Recalled
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2025 · cites it directly0descendants
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) | K230022 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2023 | — |
| +1 | K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library | 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 |
|---|---|---|
| 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.
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 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…Predicate Device(s) Device Company Predicate 510(k) Clearance Date Baxter SIGMA Baxter Healthcare K133801 04/07/2014 Spectrum Infusion Corporation Pump with Master Drug Library DESCRIP… | 2014 |
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 |
|---|---|---|---|
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library | 2025 | 0 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 20, 2025 | Class I | Z-2096-2025 | Employee error | Certain Spectrum infusion pumps may have an incorrect version of software. |
| Nov 19, 2024 | Class II | Z-0776-2025 | Process control | Devices were identified as released after repair without full testing being performed, which includes flow testing. |
| Jul 17, 2024 | Class II | Z-2581-2024 | Under Investigation by firm | The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is… |
| Jun 14, 2024 | Class II | Z-2530-2024 | Under Investigation by firm | Improperly performed testing prior to release |
| Jun 15, 2023 | Class I | Z-2103-2023 | Under Investigation by firm | A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms… |
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
What does this lineage say?
- The line of descent spans 33 years and passes through 4 companies; a new generation was cleared every 8.9 years on median.
- 6 of the 9 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K251640 (Baxter Healthcare Corporation, 2025) has gone furthest, with 0 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. 2023, 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 Baxter 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/K230022 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230022: 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 5, 2026. https://510kreport.com/device/K230022
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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