510(k) · Cleared
ClearedIda-4 and Ipt-MC
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 Dec 18, 1997 as substantially equivalent to K961862 (Bio-Tek Instruments, Inc., 1997) and 1 other predicate after an 87-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Dec 18, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- FRN
- 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 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 |
|---|---|---|---|
| * | K961862 | Models Ida-2 Plus and Ipt-1Summary page 1…ry Name: IDA-4 and IPT-MC 4- Substantially Equivalent to: The device family is equivalent to the legally marketed predicate devices: Bio-Tek Instruments, Inc. IDA-2Plus K961862 -predicate with the most similarity and some identical features; Dynatech Nevada, Model 404A, 510(k) # K897096. IDA-4 & IPT-MC… | 1997 |
| * | K897096 | Model 404A I.V. Infusion Pump AnalyzerSummary page 1…ed predicate devices: Bio-Tek Instruments, Inc. IDA-2Plus K961862 -predicate with the most similarity and some identical features; Dynatech Nevada, Model 404A, 510(k) # K897096. IDA-4 & IPT-MC and the predicate Pulse Oximeter testers have an identical intended use and there are no new technological featu… | 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 7 years and passes through 2 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 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 IDA-4 or IPT-MC 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. It is not intended to be used as an infusion device calibrator. A wide range of infusion devices can be analyzed including: syringe, drop counting, peristaltic, and volumetric types. Steady and non-steady flow rate pumps can be analyzed. The device is designed to operate using water or saline only. It incorporates an RS232 serial port for computer control/data output and a Centronics type parallel printer port.
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/K973609 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973609: Ida-4 and Ipt-MC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973609
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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