510(k) · Cleared
ClearedModels Ida-2 Plus and Ipt-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Tek Instruments, Inc. · FRN Pump, Infusion
Cleared on Feb 26, 1997 as substantially equivalent to K897096 (Dynatech/Nevada, Inc., 1990) after a 288-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.
- Decided
- Feb 26, 1997
- Review
- 288 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K897096 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK897096 Model 404A I.V. Infusion Pump AnalyzerDynatech/Nevada, Inc. · 1990
- This deviceK961862 Models Ida-2 Plus and Ipt-1Bio-Tek Instruments, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK980165 Infutest 2000 Infusion Device AnalyzerDatrend Systems, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK973609 Ida-4 and Ipt-MCBio-Tek Instruments, Inc. · 1997
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K897096 | Model 404A I.V. Infusion Pump Analyzer | Dynatech/Nevada, Inc. | 1990 | — |
| 0 (this device) | K961862 | Models Ida-2 Plus and Ipt-1 | Bio-Tek Instruments, Inc. | 1997 | — |
| +1 | K980165 | Infutest 2000 Infusion Device Analyzer | Datrend Systems, Inc. | 1998 | — |
| +1 | K973609 | Ida-4 and Ipt-MC | Bio-Tek Instruments, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K897096 | Model 404A I.V. Infusion Pump AnalyzerSummary page 2…r to other devices currently marketed in the US as infusion device testers by Datrends, Model Infutest 2000 no 510(k) # found, and Dynatech Nevada, Model 404A, 510(k) # K897096. Verification and Validation; The IDA-2Plus and its associated Graphics Capture Program was extensively verified and validated t… | 1990 |
| * | — | Datrends, Model Infutest 2000 Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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?
This device is designed to be used by manufacturers, biomedical engineering departments in hospitals and third party service organizations to verify the accurate performance of infusion devices that operate in the range stated above.
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/K961862 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961862: Models Ida-2 Plus and Ipt-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961862
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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