510(k) · Cleared
Recalled · 2004Colleague 2 Volumetric Infusion Pump (Dual Channel)/Colleague 3 Volumetric Infusion Pump (Tree Channel)
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 8, 1996 as substantially equivalent to K953098 (Baxter Healthcare Corp, 1995) and 1 other predicate after a 67-day review. Its family tree reaches back 1 generation to 1992. It has been recalled 2 times.
- Decided
- Jul 8, 1996
- Review
- 67 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K915522 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK915522 Flo-Gard (R) 6201Baxter Healthcare Corp · 1992 · Recalled
- This deviceK961703 Colleague 2 Volumetric Infusion Pump (Dual Channel)/Colleague 3…Baxter Healthcare Corp · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915522 | Flo-Gard (R) 6201 | Baxter Healthcare Corp | 1992 | 6 |
| 0 (this device) | K961703 | Colleague 2 Volumetric Infusion Pump (Dual Channel)/Colleague 3 Volumetric… | Baxter Healthcare Corp | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (2)
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 |
|---|---|---|---|
| * | K953098 | Volumetric Infusion PumpSummary page 2…vice: Colleague™ 2 Volumetric Infusion Pump Colleague™ 3 Volumetric Infusion Pump Predicate Devices: - The Colleague™ Volumetric Infusion Pump. by Baxter, cleared under K953098 on December 22, 1995 - The Flo-Gard® 6301 Volumetric Infusion Pump, by Baxter, cleared under K915522 on February 28, 1995. Devi… | 1995 |
| * | K915522 | Flo-Gard (R) 6201Summary page 2…- The Colleague™ Volumetric Infusion Pump. by Baxter, cleared under K953098 on December 22, 1995 - The Flo-Gard® 6301 Volumetric Infusion Pump, by Baxter, cleared under K915522 on February 28, 1995. Device Description and Statement of Intended Use: The Baxter Colleague™ 2 and 3 Volumetric Infusion Pumps… | 1992 |
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 |
|---|---|---|---|---|
| Nov 4, 2004 | Not classified | Z-0343-05 | 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-0880-04 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
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 Baxter Colleague™ 2 and 3 Volumetric Infusion Pumps are designed to meet the fluid delivery needs of today’s evolving health care environment. The pump can be utilized for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (I'V), intra-arterial (1A), subcutaneous, epidural or irrigation of fluid spaces applications.
Fluid delivery applications include:
= parenteral fluids, drugs and electrolytes (e.g. cardiovascular drugs, antibiotics, anesthetics, analgesics, chemotherapy agents, total parenteral nutrition products, lipids, solutions for irrigation procedures, etc.); and
* whole blood and blood products.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961703: Colleague 2 Volumetric Infusion Pump (Dual Channel)/Colleague 3 Volumetric Infusion Pump (Tree Channel).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961703
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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