Calculator, Drug Dose

FDA product code NDC · 49 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.1890
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1986-01-08 – 2026-05-27

NDC 2026-05-27

Glucommander

Applicant Glytec, LLC

K number K254102

View details →

NDC 2026-05-01

EndoTool IV Cloud 1.0

Applicant Glooko, Inc.

K number K260910

View details →

NDC 2026-01-08

MiniMed Go App

Applicant Medtronic Minimed

K number K253512

View details →

NDC 2025-12-23

UpDoc

Applicant Updoc, Inc.

K number K253281

View details →

NDC 2025-08-20

T1D1

Applicant Comerge AG

K number K252104

View details →

NDC 2024-12-11

EndoTool IV (3.1)

Applicant Monarch Medical Technologies

K number K241088

View details →

NDC 2024-11-12

InPen System App (MMT-8060 (iOS), MMT-8061 (Android))

Applicant Medtronic Minimed

K number K242775

View details →

NDC 2024-08-21

iSage Rx

Applicant Amalgam Rx, Inc.

K number K242066

View details →

NDC 2023-12-12

Insulia Bolus Companion

Applicant Voluntis Sa.

K number K232451

View details →

NDC 2023-07-28

BlueStar and BlueStar Rx

Applicant Welldoc, Inc.

K number K230813

View details →

NDC 2023-03-15

Digital Routines

Applicant Gnc Holdings, LLC

K number K221924

View details →

NDC 2021-10-28

EndoTool SubQ 2.1

Applicant Monarch Medical Technologies, LLC

K number K211160

View details →

NDC 2021-09-08

BlueStar Rx

Applicant Welldoc, Inc.

K number K203434

View details →

NDC 2021-06-04

Insulia Diabetes Management Companion

Applicant Voluntis Sa.

K number K202596

View details →

NDC 2020-08-07

EndoTool IV System

Applicant Monarch Medical Technologies, LLC

K number K201619

View details →

NDC 2020-06-18

InPen System

Applicant Companion Medical, Inc.

K number K201337

View details →

NDC 2020-03-17

EndoTool IV 1.10

Applicant Monarch Medical Technologies, LLC

K number K200443

View details →

NDC 2020-02-18

InPen Dose Calculator

Applicant Companion Medical, Inc.

K number K190487

View details →

NDC 2020-02-10

InPen System

Applicant Companion Medical, Inc.

K number K192841

View details →

NDC 2019-02-04

d-Nav System

Applicant Hygieia, Inc.

K number K181916

View details →

NDC 2018-09-20

EndoTool SubQ

Applicant Al Pacheco and Associates

K number K180366

View details →

NDC 2018-07-06

InPen Dose Calculator

Applicant Companion Medical, Inc.

K number K181327

View details →

NDC 2018-02-02

Glooko Mobile Insulin Dosing System

Applicant Glooko, Inc.

K number K171450

View details →

NDC 2017-11-07

Insulia Diabetes Management Companion

Applicant Voluntis Sa.

K number K172177

View details →

NDC 2017-09-18

Health-e-Connect System with IDA

Applicant Alr Technologies

K number K163664

View details →

NDC 2017-08-04

Glucommander

Applicant Glytec, LLC

K number K152300

View details →

NDC 2017-06-19

Insulia Diabetes Management Companion

Applicant Voluntis Sa.

K number K170669

View details →

NDC 2017-06-07

Insulin Algorithms System

Applicant Insulin Algorithms

K number K160673

View details →

NDC 2017-05-26

My Dose Coach

Applicant Sanofi

K number K171230

View details →

NDC 2017-03-22

My Dose Coach

Applicant Sanofi, Inc.

K number K163099

View details →

NDC 2017-03-07

iSage Rx (iSage Rx Basal Insulin Titration)

Applicant Isag Rx, Inc.

K number K161865

View details →

NDC 2016-12-22

Go Dose System

Applicant Eli Lilly and Company

K number K160949

View details →

NDC 2016-11-09

Insulia Diabetes Management Companion

Applicant Voluntis Sa.

K number K161433

View details →

NDC 2012-08-27

PICIS WEIGHT BASED DOSE CONVERTER

Applicant Picis, Inc.

K number K121542

View details →

NDC 2012-05-08

G+ SYSTEM

Applicant Glytec, LLC

K number K113853

View details →

NDC 2010-06-28

G+ SYSTEM

Applicant Glytec, LLC (Formally Known AS Glucotec, Inc.)

K number K101344

View details →

NDC 2008-11-07

INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER

Applicant Dimensional Dosing Systems, Inc.

K number K082512

View details →

NDC 2008-08-21

GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM

Applicant Pronia Medical System, LLC

K number K081388

View details →

NDC 2007-10-12

CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR

Applicant Medical Decisions Network

K number K071713

View details →

NDC 2006-06-14

ENDOTOOL DRUG DOSE CALCULATOR

Applicant MD Scientific, LLC

K number K053137

View details →

NDC 2006-06-07

GLUCOMMANDER PLUS

Applicant Collaborativemed, LLC

K number K061110

View details →

NDC 2005-04-08

ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE

Applicant Roche Diagnostics Corp.

K number K043529

View details →

NDC 2001-08-09

TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE

Applicant The RX Files Corp.

K number K011571

View details →

NDC 2000-10-24

PDT DOSECALCULATOR, MODEL 80000

Applicant Retinalabs.Com

K number K000418

View details →

NDC 1988-12-20

DC-1 I.V. DOSAGE COMPUTER

Applicant Phase Medical, Inc.

K number K884016

View details →

NDC 1988-10-18

DIACARE MONITORING SYSTEM

Applicant Healthware Corp.

K number K882001

View details →

NDC 1986-12-10

PHARMACOKINETICS SOFTWARE SYSTEM (PPS)

Applicant Pharmatrol, Inc.

K number K864121

View details →

NDC 1986-03-27

COMPUTER ASSISTED DIABETIC INTRUCTION

Applicant Applied Biomedical Computations, Inc.

K number K854249

View details →

NDC 1986-01-08

ABBOTT PHARAMACOKINETICS SYSTEMS

Applicant Abbott Laboratories

K number K851573

View details →