NDC · Calculator, Drug Dose · Chrysalis Intelligence

Device class

Class II

Regulation 868.1890

Total clearances

2020-02-10 → 2026-05-27

Last 12 months

Unique sponsors

Classification details

Medical specialty

Anesthesiology

Review panel

Regulation number

868.1890

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Sponsor	Clearances	Last 12 mo	Most recent
Monarch Medical Technologies	4	0	2024-12-11
Companion Medical, Inc.	3	0	2020-06-18
Voluntis Sa.	2	0	2023-12-12
Welldoc, Inc.	2	0	2023-07-28
Medtronic Minimed	2	1	2026-01-08
Comerge AG	1	0	2025-08-20
Updoc, Inc.	1	1	2025-12-23
Glooko, Inc.	1	1	2026-05-01
Glytec, LLC	1	1	2026-05-27
Amalgam Rx, Inc.	1	0	2024-08-21
Gnc Holdings, LLC	1	0	2023-03-15

Pulse

Date	K-number	Sponsor	Device
2026-05-27	K254102	Glytec, LLC	Glucommander
2026-05-01	K260910	Glooko, Inc.	EndoTool IV Cloud 1.0
2026-01-08	K253512	Medtronic Minimed	MiniMed Go App
2025-12-23	K253281	Updoc, Inc.	UpDoc
2025-08-20	K252104	Comerge AG	T1D1
2024-12-11	K241088	Monarch Medical Technologies	EndoTool IV (3.1)
2024-11-12	K242775	Medtronic Minimed	InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
2024-08-21	K242066	Amalgam Rx, Inc.	iSage Rx
2023-12-12	K232451	Voluntis Sa.	Insulia Bolus Companion
2023-07-28	K230813	Welldoc, Inc.	BlueStar and BlueStar Rx
2023-03-15	K221924	Gnc Holdings, LLC	Digital Routines
2021-10-28	K211160	Monarch Medical Technologies, LLC	EndoTool SubQ 2.1
2021-09-08	K203434	Welldoc, Inc.	BlueStar Rx
2021-06-04	K202596	Voluntis Sa.	Insulia Diabetes Management Companion
2020-08-07	K201619	Monarch Medical Technologies, LLC	EndoTool IV System
2020-06-18	K201337	Companion Medical, Inc.	InPen System
2020-03-17	K200443	Monarch Medical Technologies, LLC	EndoTool IV 1.10
2020-02-18	K190487	Companion Medical, Inc.	InPen Dose Calculator
2020-02-10	K192841	Companion Medical, Inc.	InPen System