510(k) Report

510(k) · Cleared

Cleared

Endotool Drug Dose Calculator

K053137510(k) TraditionalCleared Jun 14, 2006217-day reviewClass II21 CFR 868.1890

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

MD Scientific, LLC · NDC Calculator, Drug Dose

Cleared on Jun 14, 2006 as substantially equivalent to K011571 (The RX Files Corp., 2001) after a 217-day review. Its family tree reaches back 1 generation to 2001. 12 later devices descend from it.

Decided
Jun 14, 2006
Review
217 days
Class
Class II
Product code
NDC
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K011571 (2001). 12 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2014: 2 descendants cleared2007: 1 descendant cleared2020: 2 descendants cleared2017: 1 descendant cleared2015: 1 descendant cleared2018: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK011571 · TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite · The RX Files Corp. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K011571 · TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite · The RX Files Corp. · 20010+5
  1. Root · 1 generation backK011571 TRXF Intelligent Dosing System (Ids) -Dosing Calculator SuiteThe RX Files Corp. · 2001
  2. This deviceK053137 Endotool Drug Dose CalculatorMD Scientific, LLC · 2006
  3. Descendant · cites it directly · 8 of its ownK132547 Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014 · Recalled
  4. Descendant · 2 generations on · 3 of its ownK200443 EndoTool IV 1.10Monarch Medical Technologies, LLC · 2020
  5. Descendant · 3 generations on · 2 of its ownK201619 EndoTool IV SystemMonarch Medical Technologies, LLC · 2020
  6. Descendant · 2 generations on · 2 of its ownK142918 EndoTool SubQMonarch Medical Technologies · 2015
  7. Descendant · cites it directly · 2 of its ownK071713 Clarian Glucose Stabilizer Insulin Dosing CalculatorMedical Decisions Network · 2007

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12014: 22015: 12017: 12018: 12020: 22021: 12024: 12026: 1
2007high 2 (2014) · low 0 (2009)2026

Most influential descendants

Showing 5 of 12 · See all
  • K132547Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014 · cites it directly8descendants
  • K200443EndoTool IV 1.10Monarch Medical Technologies, LLC · 2020 · 2 generations on3descendants
  • K201619EndoTool IV SystemMonarch Medical Technologies, LLC · 2020 · 3 generations on2descendants
  • K142918EndoTool SubQMonarch Medical Technologies · 2015 · 2 generations on2descendants
  • K071713Clarian Glucose Stabilizer Insulin Dosing CalculatorMedical Decisions Network · 2007 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011571TRXF Intelligent Dosing System (Ids) -Dosing Calculator SuiteThe RX Files Corp.2001—
0 (this device)K053137Endotool Drug Dose CalculatorMD Scientific, LLC2006—
+1K132547Endo Tool Glucose Management System (Egms)Monarch Medical Technologies20141
+2K200443EndoTool IV 1.10Monarch Medical Technologies, LLC2020—
+3K201619EndoTool IV SystemMonarch Medical Technologies, LLC2020—
+2K142918EndoTool SubQMonarch Medical Technologies2015—
+1K071713Clarian Glucose Stabilizer Insulin Dosing CalculatorMedical Decisions Network2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201420
201510
201710
201810
202020
202110
202410
202610
FIG. 1 — Lineage of K053137, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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. #1 K242775 InPen System App (MMT-8060 (iOS), MMT-8061…score 18.0 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K011571TRXF Intelligent Dosing System (Ids) -Dosing Calculator SuiteThe RX Files Corp.2001—

Also cleared against K011571: 4 other devices →

What descends from it? (12)

See all 12

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132547Endo Tool Glucose Management System (Egms)Monarch Medical Technologies20148
K071713Clarian Glucose Stabilizer Insulin Dosing CalculatorMedical Decisions Network20072
K081388Glucocare Intensive Glycemic Control SystemPronia Medical System, LLC20080

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?

  • Its one ancestor has no recall.
  • Of its descendants, K132547 (Monarch Medical Technologies, 2014) has gone furthest, with 8 descendants of its own.
  • 4 other devices also cite its predicate K011571.

How does its category compare?

All NDC devices

NDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NDC

2in 2025

2007: 12008: 22010: 12012: 22014: 32015: 32016: 22017: 82018: 32019: 12020: 52021: 32023: 32024: 32025: 22026 (partial year): 4
2007high 8 (2017) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NDC

60in 2024

2014: 118 days median2015: 199 days median2017: 189 days median2018: 220 days median2020: 53 days median2021: 269 days median2023: 126 days median2024: 60 days median2026 (partial year): 90 days median
2007high 269 (2021) · low 53 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NDC

1in 2025

2016: 12017: 22018: 12019: 12022: 12025: 12026 (partial year): 2
2007high 2 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NDC

299in 2025

2008: 72009: 42010: 182011: 112012: 22013: 12014: 12015: 12016: 182017: 252018: 212019: 182020: 102021: 112022: 3472023: 4632024: 1682025: 299
2007high 463 (2023) · low 0 (2007)2025

MAUDE reports naming product code NDC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20082—07
20090—04
20101—018
20110—011
20122—02
20130—01
2014311801
2015319901
20162—118
20178189225
20183220121
20191—118
2020553010
20213269011
20220—1347
202331260463
20243600168
20252—1299
20264902—

What is it indicated for?

The EndoTooliM Drug Dose Calculator is a software support system designed for use by trained healthcare professionals to calculate any individual patient's optimal next dose for insulin administered intravenously to control blood glucose level for critically ill patients without inducing hypoglycemia (low blood glucose levels). EndoToolTM is for use with patients who are receiving a relative constant nutritional intake via intravenous fluids with dextrose, total parental nutrition or continuous gastro-intestinal feedings by any route of delivery.

Indications for use as stated in the FDA summary.

Also cleared against K011571

4 other devices cite the same predicate.

  • K163664Health-e-Connect System with IDAAlr Technologies · 2017
  • K121659Burn Resuscitation Decision Support System (Brdss)Arcos, Inc. · 20131 recall
  • K121542Picis Weight Based Dose ConverterPicis, Inc. · 2012
  • K082512Intelligent Dosing System for Insulin-MY Insulin DoserDimensional Dosing Systems, Inc. · 2008

Recent decisions in NDC

The NDC category page

  • K261939GlucommanderGlytec, LLC · 2026
  • K254102GlucommanderGlytec, LLC · 2026
  • K260910EndoTool IV Cloud 1.0Glooko, Inc. · 2026
  • K253512MiniMed Go AppMedtronic Minimed · 20262 recalls
  • K253281UpDocUpdoc, Inc. · 2025

https://510kreport.com/device/K053137 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053137: Endotool Drug Dose Calculator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053137

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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