510(k) · Cleared
Recalled · 2006Colleague Volumetric Infusion Pumps
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 Jun 25, 2004 after a 50-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 10 times.
- Decided
- Jun 25, 2004
- Review
- 50 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 10
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK041191 Colleague Volumetric Infusion PumpsBaxter Healthcare Corp · 2004
- Descendant · cites it directly · 0 of its ownK070125 Colleague Guardian Configuration Tool; Colleague DL2 Event History…Baxter Healthcare Corp · 2007
Most influential descendants
Showing 1 of 1 · See all- K070125Colleague Guardian Configuration Tool; Colleague DL2 Event History Download Software…Baxter Healthcare Corp · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041191 | Colleague Volumetric Infusion Pumps | Baxter Healthcare Corp | 2004 | — |
| +1 | K070125 | Colleague Guardian Configuration Tool; Colleague DL2 Event History Download… | Baxter Healthcare Corp | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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.
Planning a device in FRN? 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 |
|---|---|---|---|
| * | — | Colleague Volumetric Infusion Pumps Named without a submission number |
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 |
|---|---|---|---|
| K070125 | Colleague Guardian Configuration Tool; Colleague DL2 Event History Download Software… | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 6, 2006 | Not classified | Z-0483-2007 | Other | Baxter has identified the potential for a corruption of the memory chip in the pump to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual… |
| Dec 6, 2006 | Not classified | Z-0484-2007 | Other | Baxter has identified the potential for a corruption of the memory chip in the pump to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual… |
| Dec 13, 2005 | Not classified | Z-0445-06 | Device Design | Interruption of therapy due to battery undercharging, the generation of air-in-line alarms due to IV administration set tugging, and gearbox wear; and underinfusion due to misalignment of the pump head components. |
| Dec 13, 2005 | Not classified | Z-0444-06 | Device Design | Interruption of therapy due to battery undercharging, the generation of air-in-line alarms due to IV administration set tugging, and gearbox wear; and underinfusion due to misalignment of the pump head components. |
| Jul 20, 2005 | Not classified | Z-1059-05 | Device Design | A hardware problem can cause internal communications errors which halt therapies, generate alarms and communication failure codes. |
| Jul 20, 2005 | Not classified | Z-1060-05 | Device Design | A hardware problem can cause internal communications errors which halt therapies, generate alarms and communication failure codes. |
| Mar 15, 2005 | Not classified | Z-1023-05 | Device Design | The pumps may experience inadvertent power off, external communications port failures and electronic pump failure codes 402, 403, 533, 535, 599, 810:04 and 810:11. |
| Mar 15, 2005 | Not classified | Z-1022-05 | Device Design | The pumps may experience inadvertent power off, external communications port failures and electronic pump failure codes 402, 403, 533, 535, 599, 810:04 and 810:11. |
| Feb 25, 2005 | Not classified | Z-1544-05 | Labeling design | Swelling of the sealed lead-acid batteries in the infusion pump can cause internal pump damage, and excessive battery discharge can damage the batteries if the pump is left on battery power for an extended period of time after teh Battery… |
| Feb 25, 2005 | Not classified | Z-1543-05 | Labeling design | Swelling of the sealed lead-acid batteries in the infusion pump can cause internal pump damage, and excessive battery discharge can damage the batteries if the pump is left on battery power for an extended period of time after teh Battery… |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070125 (Baxter Healthcare Corp, 2007) has gone furthest, with 0 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) | — |
What is it indicated for?
Baxter Colleague Infusion Pumps are designed to meet the fluid delivery needs of today's clinically evolving health care environment. These pumps can be utilized for continuous or intermittent delivery through acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications. Fluid delivery applications include: parenteral fluids, drugs and electrolytes (e.g.…
Read the full statement (152 words)
Baxter Colleague Infusion Pumps are designed to meet the fluid delivery needs of today's clinically evolving health care environment. These pumps can be utilized for continuous or intermittent delivery through acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.
Fluid delivery applications include:
parenteral fluids, drugs and electrolytes (e.g. cardiovascular drugs, antibiotics, anesthetics, analgesics, etc.); and chemotherapy agents, total parenteral nutrition products, lipids, solutions for irrigation procedures, whole blood and blood products.
Colleague Infusion Pumps are designed to travel the continuum of care, following the patient into a variety of care areas, including, but not limited to:
Hospital: Post Anesthesia/Recovery - Blood Centers
General Floor Cardiac Cath Lab Nuclear Medicine
Medical/Surgical Emergency Room Hospice
Critical/Intensive Care Areas Burn/Trauma Units Subacute Facilities
Pediatrics/Neonatal Oncology Outpatient/Surgical Centers
Labor/Delivery/Post Partum Mobile Intensive Care Long Term Care
OR/Anesthesia Nursing Homes
Homecare*
*Colleague and Colleague CX pumps only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041191: Colleague Volumetric Infusion Pumps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041191
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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