Product Code: NDC FDA class 2 21 CFR 868.1890

Calculator, Drug Dose

Anesthesiology

The Calculator, Drug Dose (product code NDC) is an anesthesiology device used to assist clinicians in calculating appropriate drug dosages for patients. It is classified as an FDA Class 2 device, requiring 510(k) premarket clearance to demonstrate substantial equivalence to a predicate device. No specific regulation number has been assigned to this product code. The device falls within the Anesthesiology specialty and is not flagged as an implant or life-sustaining device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: NDC
Device Class: FDA class 2
Regulation Number: 868.1890
Medical Specialty: Anesthesiology
Review Panel: CH
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 55 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K254102	Glucommander	May 27, 2026	Substantially Equivalent	Glytec, LLC
K260910	EndoTool IV Cloud 1.0	May 01, 2026	Substantially Equivalent	Glooko, Inc.
K253512	MiniMed Go App	Jan 08, 2026	Substantially Equivalent	Medtronic Minimed
K253281	UpDoc	Dec 23, 2025	Substantially Equivalent	Updoc, Inc.
K252104	T1D1	Aug 20, 2025	Substantially Equivalent	Comerge AG
K241088	EndoTool IV (3.1)	Dec 11, 2024	Substantially Equivalent	Monarch Medical Technologies
K242775	InPen System App (MMT-8060 (iOS), MMT-8061 (Android))	Nov 12, 2024	Substantially Equivalent	Medtronic Minimed
K242066	iSage Rx	Aug 21, 2024	Substantially Equivalent	Amalgam Rx, Inc.
K232451	Insulia Bolus Companion	Dec 12, 2023	Substantially Equivalent	Voluntis Sa.
K230813	BlueStar and BlueStar Rx	Jul 28, 2023	Substantially Equivalent	Welldoc, Inc.
K221924	Digital Routines	Mar 15, 2023	Substantially Equivalent	Gnc Holdings, LLC
K211160	EndoTool SubQ 2.1	Oct 28, 2021	Substantially Equivalent	Monarch Medical Technologies, LLC
K203434	BlueStar Rx	Sep 08, 2021	Substantially Equivalent	Welldoc, Inc.
K202596	Insulia Diabetes Management Companion	Jun 04, 2021	Substantially Equivalent	Voluntis Sa.
K201619	EndoTool IV System	Aug 07, 2020	Substantially Equivalent	Monarch Medical Technologies, LLC
K201337	InPen System	Jun 18, 2020	Substantially Equivalent	Companion Medical, Inc.
K200443	EndoTool IV 1.10	Mar 17, 2020	Substantially Equivalent	Monarch Medical Technologies, LLC
K190487	InPen Dose Calculator	Feb 18, 2020	Substantially Equivalent	Companion Medical, Inc.
K192841	InPen System	Feb 10, 2020	Substantially Equivalent	Companion Medical, Inc.
K181916	d-Nav System	Feb 04, 2019	Substantially Equivalent	Hygieia, Inc.
K180366	EndoTool SubQ	Sep 20, 2018	Substantially Equivalent	Al Pacheco and Associates
K181327	InPen Dose Calculator	Jul 06, 2018	Substantially Equivalent	Companion Medical, Inc.
K171450	Glooko Mobile Insulin Dosing System	Feb 02, 2018	Substantially Equivalent	Glooko, Inc.
K172177	Insulia Diabetes Management Companion	Nov 07, 2017	Substantially Equivalent	Voluntis Sa.
K163664	Health-e-Connect System with IDA	Sep 18, 2017	Substantially Equivalent	Alr Technologies
K152300	Glucommander	Aug 04, 2017	Substantially Equivalent	Glytec, LLC
K170669	Insulia Diabetes Management Companion	Jun 19, 2017	Substantially Equivalent	Voluntis Sa.
K160673	Insulin Algorithms System	Jun 07, 2017	Substantially Equivalent	Insulin Algorithms
K171230	My Dose Coach	May 26, 2017	Substantially Equivalent	Sanofi
K163099	My Dose Coach	Mar 22, 2017	Substantially Equivalent	Sanofi, Inc.
K161865	iSage Rx (iSage Rx Basal Insulin Titration)	Mar 07, 2017	Substantially Equivalent	Isag Rx, Inc.
K160949	Go Dose System	Dec 22, 2016	Substantially Equivalent	Eli Lilly and Company
K161433	Insulia Diabetes Management Companion	Nov 09, 2016	Substantially Equivalent	Voluntis Sa.
K150910	ACCU-CHEK Connect Diabetes Management App	Jun 03, 2015	Substantially Equivalent	Roche Diabetes Care, Inc.
K142918	EndoTool SubQ	Apr 24, 2015	Substantially Equivalent	Monarch Medical Technologies
K141929	ACCU-CHEK CONNECT DIABETES MANAGEMENT APP	Mar 16, 2015	Substantially Equivalent	Roche Diagnostics Corporation
K142123	REACH ACCESS TELEMEDICINE DOSE CALCULATOR	Sep 24, 2014	Substantially Equivalent	Reach Health, Inc.
K141321	GLUCOSTABILIZER INSULIN DOSING CALCULATOR	Sep 15, 2014	Substantially Equivalent	Medical Decision Network
K132547	ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)	Apr 17, 2014	Substantially Equivalent	Monarch Medical Technologies
K121542	PICIS WEIGHT BASED DOSE CONVERTER	Aug 27, 2012	Substantially Equivalent	Picis, Inc.
K113853	G+ SYSTEM	May 08, 2012	Substantially Equivalent	Glytec, LLC
K101344	G+ SYSTEM	Jun 28, 2010	Substantially Equivalent	Glytec, LLC (Formally Known AS Glucotec, Inc.)
K082512	INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER	Nov 07, 2008	Substantially Equivalent	Dimensional Dosing Systems, Inc.
K081388	GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM	Aug 21, 2008	Substantially Equivalent	Pronia Medical System, LLC
K071713	CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR	Oct 12, 2007	Substantially Equivalent	Medical Decisions Network
K053137	ENDOTOOL DRUG DOSE CALCULATOR	Jun 14, 2006	Substantially Equivalent	MD Scientific, LLC
K061110	GLUCOMMANDER PLUS	Jun 07, 2006	Substantially Equivalent	Collaborativemed, LLC
K043529	ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE	Apr 08, 2005	Substantially Equivalent	Roche Diagnostics Corp.
K011571	TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE	Aug 09, 2001	Substantially Equivalent	The RX Files Corp.
K000418	PDT DOSECALCULATOR, MODEL 80000	Oct 24, 2000	Substantially Equivalent	Retinalabs.Com
K884016	DC-1 I.V. DOSAGE COMPUTER	Dec 20, 1988	Substantially Equivalent	Phase Medical, Inc.
K882001	DIACARE MONITORING SYSTEM	Oct 18, 1988	Substantially Equivalent	Healthware Corp.
K864121	PHARMACOKINETICS SOFTWARE SYSTEM (PPS)	Dec 10, 1986	Substantially Equivalent	Pharmatrol, Inc.
K854249	COMPUTER ASSISTED DIABETIC INTRUCTION	Mar 27, 1986	Substantially Equivalent	Applied Biomedical Computations, Inc.
K851573	ABBOTT PHARAMACOKINETICS SYSTEMS	Jan 08, 1986	Substantially Equivalent	Abbott Laboratories