510(k) · Cleared
ClearedColleague Guardian Configuration Tool; Colleague DL2 Event History Download Software Application
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 Apr 16, 2007 as substantially equivalent to K041191 (Baxter Healthcare Corp, 2004) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Apr 16, 2007
- Review
- 90 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010566 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK010566 Colleague Volumetric Infusion PumpBaxter Healthcare Corp · 2001 · Recalled
- This deviceK070125 Colleague Guardian Configuration Tool; Colleague DL2 Event History…Baxter Healthcare Corp · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010566 | Colleague Volumetric Infusion Pump | Baxter Healthcare Corp | 2001 | 2 |
| 0 (this device) | K070125 | Colleague Guardian Configuration Tool; Colleague DL2 Event History Download… | Baxter Healthcare Corp | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K041191 | Colleague Volumetric Infusion PumpsSummary page 1…80.5725 Class: II Equivalent Predicate: COLLEAGUE Volumetric Infusion Pump and Software Accessories, K041191 and K010566 Device Description: The COLLEAGUE GUARDIAN Configuration Tool is a propr… | 2004 |
| * | K010566 | Colleague Volumetric Infusion PumpSummary page 1…ss: II Equivalent Predicate: COLLEAGUE Volumetric Infusion Pump and Software Accessories, K041191 and K010566 Device Description: The COLLEAGUE GUARDIAN Configuration Tool is a proprietary, Pers… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
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. 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 GUARDIAN Configuration Tool is a proprietary, Personal Computer (PC) based software accessory that is used to define, create and maintain the COLLEAGUE Personality Feature Sets, Labels and rule sets (COLLEAGUE GUARDIAN Configurations) associated with the COLLEAGUE GUARDIAN feature. This software accessory can be utilized with product codes of the COLLEAGUE Volumetric Infusion Pump that contain the COLLEAGUE GUARDIAN feature. The COLLEAGUE…
Read the full statement (113 words)
The COLLEAGUE GUARDIAN Configuration Tool is a proprietary, Personal Computer (PC) based software accessory that is used to define, create and maintain the COLLEAGUE Personality Feature Sets, Labels and rule sets (COLLEAGUE GUARDIAN Configurations) associated with the COLLEAGUE GUARDIAN feature. This software accessory can be utilized with product codes of the COLLEAGUE Volumetric Infusion Pump that contain the COLLEAGUE GUARDIAN feature.
The COLLEAGUE DL2 Event History Download Software Application is a proprietary, Personal Computer (PC) based software accessory. It provides access to event history information from all product codes of the COLLEAGUE Volumetric Infusion Pump, which can then be downloaded, viewed, printed and copied to the Windows Clipboard for pasting into other programs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070125 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070125: Colleague Guardian Configuration Tool; Colleague DL2 Event History Download Software Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070125
Report an extraction error
Are you the manufacturer?
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