510(k) · Cleared
ClearedTRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The RX Files Corp. · NDC Calculator, Drug Dose
Cleared on Aug 9, 2001 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 22 later devices descend from it.
- Decided
- Aug 9, 2001
- Review
- 80 days
- Class
- Class II
- Product code
- NDC
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 5 citing it directly.
- This deviceK011571 TRXF Intelligent Dosing System (Ids) -Dosing Calculator SuiteThe RX Files Corp. · 2001
- Descendant · cites it directly · 12 of its ownK053137 Endotool Drug Dose CalculatorMD Scientific, LLC · 2006
- Descendant · 2 generations on · 8 of its ownK132547 Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014 · Recalled
- Descendant · cites it directly · 4 of its ownK082512 Intelligent Dosing System for Insulin-MY Insulin DoserDimensional Dosing Systems, Inc. · 2008
- Descendant · 3 generations on · 3 of its ownK200443 EndoTool IV 1.10Monarch Medical Technologies, LLC · 2020
- Descendant · 4 generations on · 2 of its ownK201619 EndoTool IV SystemMonarch Medical Technologies, LLC · 2020
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K053137Endotool Drug Dose CalculatorMD Scientific, LLC · 2006 · cites it directly12descendants
- K132547Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014 · 2 generations on8descendants
- K082512Intelligent Dosing System for Insulin-MY Insulin DoserDimensional Dosing Systems, Inc. · 2008 · cites it directly4descendants
- K200443EndoTool IV 1.10Monarch Medical Technologies, LLC · 2020 · 3 generations on3descendants
- K201619EndoTool IV SystemMonarch Medical Technologies, LLC · 2020 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011571 | TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite | The RX Files Corp. | 2001 | — |
| +1 | K053137 | Endotool Drug Dose Calculator | MD Scientific, LLC | 2006 | — |
| +2 | K132547 | Endo Tool Glucose Management System (Egms) | Monarch Medical Technologies | 2014 | 1 |
| +1 | K082512 | Intelligent Dosing System for Insulin-MY Insulin Doser | Dimensional Dosing Systems, Inc. | 2008 | — |
| +3 | K200443 | EndoTool IV 1.10 | Monarch Medical Technologies, LLC | 2020 | — |
| +4 | K201619 | EndoTool IV System | Monarch Medical Technologies, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NDC? 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 NDC device
- #1 K242775 InPen System App (MMT-8060 (iOS), MMT-8061…score 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (22)
See all 225 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?
- Of its descendants, K053137 (MD Scientific, LLC, 2006) has gone furthest, with 12 descendants of its own.
How does its category compare?
All NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NDC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDC
60in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDC
299in 2025
MAUDE reports naming product code NDC, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 3 | 118 | 0 | 1 |
| 2015 | 3 | 199 | 0 | 1 |
| 2016 | 2 | — | 1 | 18 |
| 2017 | 8 | 189 | 2 | 25 |
| 2018 | 3 | 220 | 1 | 21 |
| 2019 | 1 | — | 1 | 18 |
| 2020 | 5 | 53 | 0 | 10 |
| 2021 | 3 | 269 | 0 | 11 |
| 2022 | 0 | — | 1 | 347 |
| 2023 | 3 | 126 | 0 | 463 |
| 2024 | 3 | 60 | 0 | 168 |
| 2025 | 2 | — | 1 | 299 |
| 2026 | 4 | 90 | 2 | — |
What is it indicated for?
The Intelligent Dosing System (IDS)™ is a three-part software suite comprised of DoseRx™, InterchangeRx™ and PracticePrescribeRx™. The DoseRx™ is designed for use by trained clinicians to calculate any individual patient’s optimal next dose for any given agent. The InterchangeRx™ is designed to switch a patient from one brand of agent to another while maintaining the therapeutic effect of the original agent. The PracticePrescirbeRx is a dosing simulator…
Read the full statement (169 words)
The Intelligent Dosing System (IDS)™ is a three-part software suite comprised of DoseRx™, InterchangeRx™ and PracticePrescribeRx™. The DoseRx™ is designed for use by trained clinicians to calculate any individual patient’s optimal next dose for any given agent. The InterchangeRx™ is designed to switch a patient from one brand of agent to another while maintaining the therapeutic effect of the original agent. The PracticePrescirbeRx is a dosing simulator that offers graded prescriber training of next dose calculation scenarios with scalable patient response and surrogate marker inputs that allows the healthcare provider to gain guided and measured experience in calculating the next dose for a new or infrequently used drug.
The IDS™ is not a substitute for clinical reasoning. The IDS™ is an aid for trained clinicians based upon significant and properly entered data. Final drug dose recommendations for a patient must be made only after careful consideration of the full clinical status of the patient. No medical decision should be based solely upon the results provided by this software program.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011571 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011571: TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011571
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026