510(k) · Cleared
Recalled · 2011Colleague Volumetric Infusion Pump Model# 2M8151,8153,8161,8163,9161,9163
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxterhealthcare, Inc. · FRN Pump, Infusion
Cleared on Feb 27, 2007 after a 76-day review. The FDA summary names its predicate without a number. It has been recalled 19 times.
- Decided
- Feb 27, 2007
- Review
- 76 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 19
- Predicates
- 0
The FDA summary names its predicate without a number.
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
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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 Pump (currently marketed models: COLLEAGUE, COLLEAGUE CX… Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 22, 2011 | Not classified | Z-2958-2011 | Other | Baxter's Service Center tested and returned to the user the Colleague infusion pump that did not meet PSIG (Pounds-force per Square Inch) specifications |
| Jul 22, 2011 | Not classified | Z-3007-2011 | Process design | The Colleague infusion pump may not have met certain Air in Line (AIL) specifications after testing by the Baxter Global Technical Service Center. This issue could potentially cause a delay in initiation of therapy. |
| Jul 22, 2011 | Not classified | Z-3008-2011 | Other | A review of Baxter service records indicates that the Baxter Colleague CX Infusion Pump has not met certain voltage specifications. This issue could potentially cause a delay in initiation of therapy. |
| Jul 5, 2011 | Not classified | Z-2853-2011 | Process control | While replacing a defective pump head mechanism and performing calibration, Baxter's Service center may have failed to apply GLYPTOL (a red insulating varnish) on a potentiometer that helps maintain pump accuracy for detecting an air bolus. |
| May 4, 2011 | Not classified | Z-2796-2011 | Employee error | The Air In Line (AIL) test was not properly performed by the service technician at the Service Center. |
| Apr 14, 2011 | Not classified | Z-2222-2011 | Employee error | The Hi-Pot safety testing may not have been conducted on the affected pumps during service, prior to being returned to the end user. |
| Dec 1, 2010 | Not classified | Z-0935-2011 | Employee error | The Air In Line (AIL) test was not properly performed by the service technician at the Service Center. |
| Dec 1, 2010 | Not classified | Z-0931-2011 | Employee error | While the infusion pump was being serviced at the Baxter Service Center, it was inadvertently routed to the packaging area before the final inspection. |
| Aug 4, 2010 | Not classified | Z-0001-2011 | Device Design | The FDA sent a letter to Baxter on April 30, 2010, ordering the company to recall and destroy all models of its Colleague Volumetric Infusion Pumps currently in use in the United States. FDA determined that this action is necessary, as… |
| Aug 4, 2010 | Not classified | Z-0002-2011 | Device Design | The FDA sent a letter to Baxter on April 30, 2010, ordering the company to recall and destroy all models of its Colleague Volumetric Infusion Pumps currently in use in the United States. FDA determined that this action is necessary, as… |
| Jul 14, 2010 | Not classified | Z-0744-2012 | Employee error | Baxter's Service Center did not perform the ground impedance and leakage current test which verify if any power overflow occurs and that it is properly discharged through the device electrical system. |
| Jul 14, 2010 | Not classified | Z-0745-2012 | Employee error | Baxter's Service Center did not perform the ground impedance and leakage current test which verify if any power overflow occurs and that it is properly discharged through the device electrical system. |
| May 8, 2009 | Not classified | Z-0598-2012 | Process control | There was no documentation to show the required tests were performed following the replacement of the battery and battery harness. |
| Jan 23, 2009 | Not classified | Z-1038-2009 | Device Design | Baxter has identified failure codes that lead to a delay or an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages for the Colleague Infusion Pumps. |
| Jan 23, 2009 | Not classified | Z-1037-2009 | Device Design | Baxter has identified failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages for the Colleague Infusion Pumps. |
| Aug 15, 2007 | Not classified | Z-1224-2007 | Other | Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade. |
| Jun 21, 2007 | Not classified | Z-1114-2007 | Other | Falsified Repair/Test and Inspection records: Pumps submitted for repair or service may not have been properly repaired or serviced before being returned to the customer. |
| Jun 21, 2007 | Not classified | Z-1113-2007 | Other | Falsified Repair/Test and Inspection records: Pumps submitted for repair or service may not have been properly repaired or serviced before being returned to the customer. |
| Jun 20, 2007 | Not classified | Z-1091-2007 | Software design | A software anomaly is causing newly upgraded Colleague Triple Channel Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels simultaneously… |
The 5 latest of 19 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 COLLEAGUE Volumetric Infusion Pump is capable of delivering medications, solutions, parenteral nutrition, lipids, blood and blood components. The COLLEAGUE pump is designed to deliver infusion therapies via clinically acceptable routes of administration, including intravenous, intra-arterial, epidural, and subcutaneous routes. The COLLEAGUE pump is intended for use in a wide variety of patient care environments for adult, pediatric and neonatal…
Read the full statement (169 words)
The COLLEAGUE Volumetric Infusion Pump is capable of delivering medications, solutions, parenteral nutrition, lipids, blood and blood components.
The COLLEAGUE pump is designed to deliver infusion therapies via clinically acceptable routes of administration, including intravenous, intra-arterial, epidural, and subcutaneous routes.
The COLLEAGUE pump is intended for use in a wide variety of patient care environments for adult, pediatric and neonatal patients. The COLLEAGUE pump facilitates the delivery of routine and critical infusion therapies via continuous and intermittent delivery using primary and piggyback, infusion modes.
The COLLEAGUE pump can be used in the following care areas:
* General Floor of the Hospital
* Critical / Intensive Care
* Neonatal Intensive Care
* Pediatric Care
* Labor / Delivery / Postpartum
* Operating Room / Anesthesia
* Post Anesthesia / Recovery
* Cardiac Catheterization Lab
* Emergency Room
* Ground Ambulance
* Hospice Facility
* Outpatient / Subacute Facilities
* Nursing Facilities
* Long Term Care / Rehabilitation Facilities
* Diagnostic Nuclear Medicine
* Oncology Floor
* Burn Unit / Trauma
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063696 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063696: Colleague Volumetric Infusion Pump Model# 2M8151,8153,8161,8163,9161,9163.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063696
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026