510(k) · Cleared
ClearedInfutest 2000 Infusion Device Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datrend Systems, Inc. · MRZ Accessories, Pump, Infusion
Cleared on Apr 20, 1998 as substantially equivalent to K961862 (Bio-Tek Instruments, Inc., 1997) and 1 other predicate after a 94-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Apr 20, 1998
- Review
- 94 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K897096 (1990). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 MRZ? 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 MRZ device
- #1 K193654 BlueStar Rxscore 7.5 · 9 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 |
|---|---|---|---|
| * | K961862 | Models Ida-2 Plus and Ipt-1Summary page 1…me: Infutest 2000 Equivalency: The Datrend Systems Infutest 2000 Infusion Pump Analyzer is substantially equivalent to the Bio-Tek IDA-2 Plus Infusion Device Analyzer (K961862) and the DNI Nevada 404A Infusion Pump Analyzer (K897096). Description: The Infutest 2000 Infusion Pump Analyzer is an instrume… | 1997 |
| * | K897096 | Model 404A I.V. Infusion Pump AnalyzerSummary page 1…test 2000 Infusion Pump Analyzer is substantially equivalent to the Bio-Tek IDA-2 Plus Infusion Device Analyzer (K961862) and the DNI Nevada 404A Infusion Pump Analyzer (K897096). Description: The Infutest 2000 Infusion Pump Analyzer is an instrument for measuring the volume of fluid delivered by an infu… | 1990 |
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K961862.
How does its category compare?
All MRZ devicesMRZ Accessories, Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MRZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MRZ
96in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRZ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRZ
35in 2025
MAUDE reports naming product code MRZ, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 96 | 0 | 0 |
| 2009 | 2 | — | 1 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 117 |
| 2016 | 2 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 1 | — | 1 | 46 |
| 2019 | 1 | — | 5 | 36 |
| 2020 | 2 | — | 0 | 44 |
| 2021 | 1 | — | 0 | 61 |
| 2022 | 1 | — | 0 | 39 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Infutest 2000 Infusion Device Analyzer (Infutest) is intended to verify the correct operation of infusion pumps. Infutest is designed to be used by biomedical electronics technicians, third party service personnel, and others who may be charged with the responsibility of determining the functionality of an infusion pump.
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/K980165 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980165: Infutest 2000 Infusion Device Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980165
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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