510(k) · Cleared
Recalled · 2004Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump 2M8151
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FRN Pump, Infusion
Cleared on Jul 28, 2000 after a 7-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 of the 44 devices in its family, counting itself, have a Class I recall. 43 later devices descend from it. It has been recalled 4 times.
- Decided
- Jul 28, 2000
- Review
- 7 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 4
- Predicates
- 0
43 later devices descend from it, 2 citing it directly. 12 of the 44 devices in this family, counting this one, have a Class I recall.
- This deviceK002211 Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric…Baxter Healthcare Corp · 2000
- Descendant · cites it directly · 28 of its ownK042121 Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Recalled (Class I)
- Descendant · 2 generations on · 18 of its ownK133801 Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · Recalled (Class I)
- Descendant · cites it directly · 13 of its ownK012383 Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE)…Alaris Medical Systems, Inc. · 2001 · Recalled (Class I)
- Descendant · 3 generations on · 9 of its ownK173084 Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · Recalled (Class I)
- Descendant · 2 generations on · 7 of its ownK123049 Sapphire Infusion PumpQ Core Medical, Ltd. · 2013
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K042121 Spectrum and Spectrum with Master Drug Librarycites it directly · 2004
- K012383 Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition…cites it directly · 2001
- K090087 Mridium 3860 Mri Infusion Pump/Monitoring System2 generations on · 2009
- K133532 Alaris System with Guardrails Suite MX2 generations on · 2014
Most influential descendants
Showing 5 of 43 · See all- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · cites it directly28descendants
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 2 generations on18descendants
- K012383Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii…Alaris Medical Systems, Inc. · 2001 · cites it directly13descendants
- K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · 3 generations on9descendants
- K123049Sapphire Infusion PumpQ Core Medical, Ltd. · 2013 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002211 | Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump… | Baxter Healthcare Corp | 2000 | — |
| +1 | 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 | K012383 | Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem… | Alaris Medical Systems, Inc. | 2001 | Class I |
| +3 | K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software | Baxter Healthcare Corporation | 2018 | Class I |
| +2 | K123049 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 1 |
| 2003 | 1 | 0 |
| 2004 | 1 | 1 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 1 |
| 2013 | 1 | 0 |
| 2014 | 5 | 2 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 1 |
| 2019 | 1 | 1 |
| 2020 | 2 | 1 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 3 |
| 2024 | 3 | 1 |
| 2025 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
12 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (43)
See all 432 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (12 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2004 | Not classified | Z-0344-05 | Other | A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient. |
| Nov 4, 2004 | Not classified | Z-0345-05 | Other | A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient. |
| Apr 13, 2004 | Not classified | Z-0882-04 | Nonconforming Material/Component | Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time. |
| Apr 13, 2004 | Not classified | Z-0881-04 | Nonconforming Material/Component | Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time. |
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 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 13 Class I recalls
- K012383Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii)…Alaris Medical Systems, Inc. · 2001 · Cites it directly · ◆ in the 2001 descendants bar of FIG. 13 Class I recalls
- K090087Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 128 Class I recalls
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 15 Class I recalls
- K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 17 Class I recalls
- K230022Baxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
- K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 14 Class I recalls
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls
- K211122Novum IQ Large Volume PumpBaxter Healthcare Corporation · 2024 · 4 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 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 12; all are on the web page.
What does this lineage say?
- Of its descendants, K042121 (Sigma Intl., 2004) has gone furthest, with 28 descendants of its own.
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) | — |
https://510kreport.com/device/K002211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002211: Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump 2M8151.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002211
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026