NDC · Class II · 21 CFR 868.1890

FDA Product Code NDC: Calculator, Drug Dose

Leading manufacturers include Voluntis Sa., Companion Medical, Inc. and Glytec, LLC.

55
Total
55
Cleared
158d
Avg days
1986
Since
Growing category - 7 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 99d recently vs 167d historically

FDA 510(k) Cleared Calculator, Drug Dose Devices (Product Code NDC)

55 devices
1–24 of 55
Cleared May 27, 2026
Glucommander
K254102
Glytec, LLC
Chemistry · 159d
Cleared May 01, 2026
EndoTool IV Cloud 1.0
K260910
Glooko, Inc.
Chemistry · 43d
Cleared Jan 08, 2026
MiniMed Go App
K253512
Medtronic Minimed
Chemistry · 63d
Cleared Dec 23, 2025
UpDoc
K253281
Updoc, Inc.
Chemistry · 85d
Cleared Aug 20, 2025
T1D1
K252104
Comerge AG
Chemistry · 48d
Cleared Dec 11, 2024
EndoTool IV (3.1)
K241088
Monarch Medical Technologies
Chemistry · 236d
Cleared Nov 12, 2024
InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
K242775
Medtronic Minimed
Chemistry · 60d
Cleared Aug 21, 2024
iSage Rx
K242066
Amalgam Rx, Inc.
Chemistry · 37d
Cleared Dec 12, 2023
Insulia Bolus Companion
K232451
Voluntis Sa.
Chemistry · 120d
Cleared Jul 28, 2023
BlueStar and BlueStar Rx
K230813
Welldoc, Inc.
Chemistry · 126d
Cleared Mar 15, 2023
Digital Routines
K221924
Gnc Holdings, LLC
Chemistry · 257d
Cleared Oct 28, 2021
EndoTool SubQ 2.1
K211160
Monarch Medical Technologies, LLC
Chemistry · 192d
Cleared Sep 08, 2021
BlueStar Rx
K203434
Welldoc, Inc.
Chemistry · 289d
Cleared Jun 04, 2021
Insulia Diabetes Management Companion
K202596
Voluntis Sa.
Chemistry · 269d
Cleared Aug 07, 2020
EndoTool IV System
K201619
Monarch Medical Technologies, LLC
Chemistry · 53d
Cleared Jun 18, 2020
InPen System
K201337
Companion Medical, Inc.
General Hospital · 29d
Cleared Mar 17, 2020
EndoTool IV 1.10
K200443
Monarch Medical Technologies, LLC
Chemistry · 22d
Cleared Feb 18, 2020
InPen Dose Calculator
K190487
Companion Medical, Inc.
Chemistry · 355d
Cleared Feb 10, 2020
InPen System
K192841
Companion Medical, Inc.
General Hospital · 130d
Cleared Feb 04, 2019
d-Nav System
K181916
Hygieia, Inc.
General Hospital · 202d
Cleared Sep 20, 2018
EndoTool SubQ
K180366
Al Pacheco and Associates
General Hospital · 220d
Cleared Jul 06, 2018
InPen Dose Calculator
K181327
Companion Medical, Inc.
General Hospital · 49d
Cleared Feb 02, 2018
Glooko Mobile Insulin Dosing System
K171450
Glooko, Inc.
General Hospital · 261d
Cleared Nov 07, 2017
Insulia Diabetes Management Companion
K172177
Voluntis Sa.
General Hospital · 111d

About Product Code NDC - Regulatory Context

510(k) Submission Activity

55 total 510(k) submissions under product code NDC since 1986, with 55 receiving FDA clearance (average review time: 158 days).

Submission volume has increased in recent years - 7 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - NDC Product Code

Recent submissions under NDC have taken an average of 99 days to reach a decision - down from 167 days historically, suggesting improved FDA processing for this classification.

NDC devices are reviewed by the General Hospital panel. Browse all General Hospital devices →