510(k) · Cleared
Recalled · Class I · 2021Spectrum and Spectrum with Master Drug Library
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Intl. · FRN Pump, Infusion
Cleared on Aug 26, 2004 as substantially equivalent to K030459 (Alaris Medical Systems, Inc., 2003) and 3 other predicates after a 20-day review. Its family tree reaches back 3 generations to 1990. 10 of the 36 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it. It has been recalled 18 times, including 3 Class I recalls.
- Decided
- Aug 26, 2004
- Review
- 20 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 18 (3 Class I)
- Predicates
- 4
Its longest line of descent runs back 3 generations to K904518 (1990). 7 ancestors in all. 28 later devices descend from it, 3 citing it directly. 10 of the 36 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 2 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 1 generation backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- This deviceK042121 Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004
- Descendant · cites it directly · 18 of its ownK133801 Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 9 of its ownK173084 Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · Recalled (Class I)
- Descendant · cites it directly · 7 of its ownK123049 Sapphire Infusion PumpQ Core Medical, Ltd. · 2013
- Descendant · 2 generations on · 5 of its ownK142374 ivWatch Model 400Ivwatch, LLC · 2015
- Descendant · 3 generations on · 4 of its ownK153605 ivWatch Model 400Ivwatch, LLC · 2016
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 28 · See all- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · cites it directly18descendants
- K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · 2 generations on9descendants
- K123049Sapphire Infusion PumpQ Core Medical, Ltd. · 2013 · cites it directly7descendants
- K142374ivWatch Model 400Ivwatch, LLC · 2015 · 2 generations on5descendants
- K153605ivWatch Model 400Ivwatch, LLC · 2016 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −2 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −1 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| 0 (this device) | K042121 | Spectrum and Spectrum with Master Drug Library | Sigma Intl. | 2004 | — |
| +1 | K133801 | Baxter Sigma Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2014 | Class I |
| +2 | K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software | Baxter Healthcare Corporation | 2018 | Class I |
| +1 | K123049 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2013 | — |
| +2 | K142374 | ivWatch Model 400 | Ivwatch, LLC | 2015 | — |
| +3 | K153605 | ivWatch Model 400 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 1 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 1 |
| 2019 | 1 | 1 |
| 2020 | 2 | 1 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 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.
10 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? (4)
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 |
|---|---|---|---|
| * | K030459 | Medley System with Medication Management System (MMS)Summary page 2…Master Drug Library are identified as follows: Premarket Device Name Applicant Notification, 510(k) Number K030459 Medley' TM System with Medication ALARIS Medical Systems, Managem… | 2003 |
| * | K011975 | Horizon Outlook with DosecomSummary page 2…59 Medley' TM System with Medication ALARIS Medical Systems, Management System Inc. K011975 Horizon OutlookT M with B. Braun Medical Inc. DoseComTM Th… | 2001 |
| * | K950766 | Sigma 8000 and Sigma 8002Summary page 3…510(k) Summary (continuation) Premarket Device Name Applicant Notification, 510(k) Number K950766 SIGMA Model 8000 and 8002 SIGMA International General Infusion Pumps… | 1995 |
| * | K002211 | Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump 2M8151Summary page 3…Number K950766 SIGMA Model 8000 and 8002 SIGMA International General Infusion Pumps Medical Apparatus, LLC. K002211 Colleague® CX Volumetric Baxter Healthcare Infusion Pump… | 2000 |
What descends from it? (28)
See all 283 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (10 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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-0713-2021 | Under Investigation by firm | There is a potential software error during programming. |
| Nov 23, 2020 | Class II | Z-0712-2021 | Under Investigation by firm | There is a potential software error during programming. |
| Jun 30, 2020 | Class I | Z-0120-2021 | Labeling design | Baxter is updating the device IFU for safety communication regarding cleaning practices. |
| May 8, 2018 | Class II | Z-2112-2018 | 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… |
| Apr 3, 2018 | Class II | Z-1667-2018 | Employee error | Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at… |
| Apr 3, 2018 | Class II | Z-1664-2018 | Employee error | Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at… |
| Apr 3, 2018 | Class II | Z-1666-2018 | Employee error | Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at… |
| Apr 3, 2018 | Class II | Z-1665-2018 | Employee error | Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at… |
| Apr 3, 2018 | Class II | Z-1663-2018 | Employee error | Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at… |
| Sep 28, 2016 | Class II | Z-0670-2017 | 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 3, 2014 | Class II | Z-2738-2014 | Equipment maintenance | One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014. |
| Feb 7, 2014 | Class I | Z-1484-2014 | Software design | Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences. |
| Sep 24, 2013 | Class II | Z-0189-2014 | Under Investigation by firm | Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion Pump with Master Drug Library for not meeting standards for withstanding an electrostatic discharge. |
| Jun 10, 2013 | Class II | Z-0197-2014 | Process design | Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions. |
| Apr 23, 2012 | Class III | Z-2030-2012 | Software design | Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library that does not represent common clinical practices. |
| Jul 6, 2011 | Class I | Z-1490-2012 | Nonconforming Material/Component | Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion. Sigma's evaluation of subsequent… |
| Sep 15, 2010 | Not classified | Z-0146-2011 | Device Design | The infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion. |
The 5 latest of 18 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.
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 15 Class I recalls
- K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K230022Baxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
- K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 14 Class I recalls
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls
- K211122Novum IQ Large Volume PumpBaxter Healthcare Corporation · 2024 · 3 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 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 7 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K133801 (Baxter Healthcare Corporation, 2014) has gone furthest, with 18 descendants of its own.
- 8 other devices also cite its predicate K030459.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 and Spectrum with Master Drug Library is intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically acceptable routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. The spectrum is intended to be…
Read the full statement (150 words)
The Spectrum and Spectrum with Master Drug Library is intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically acceptable routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. The spectrum is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user.
The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services.
The Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to physician's directive.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042121 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042121: Spectrum and Spectrum with Master Drug Library.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042121
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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