510(k) K161865
- Device
- ISage Rx (iSage Rx Basal Insulin Titration)
- Applicant
- ISag Rx, Inc.
- 510(k) number
- K161865
- Product code
- NDC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-03-07
- Date received
- 2016-07-07
- Regulation
- 868.1890
- Classification name
- Calculator, Drug Dose
- Medical specialty
- Anesthesiology
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RYAN SYSKO
- Address
- 206 Alapocas Dr. Wilmington DE US 19803 19803
FDA Registration Numbers#
- 3007981285
- 3044561902
- 3006400278
- 3015192982
- 3010817588
- 3025343017
- 3013922904
- 1220477
- 3009864844
- 2219920
- 3042952037
- 3013498633
- 1220973
- 3016540876
- 3008770957
- 3005244943
- 3005853093
- 3005627859
- 3017986070
- 3013756811
- 1313700
- 3011393376
- 3042027705
- 3020976354
- 2032227
- 3014174631
- 3008810357
- 3016798778
- 3012421607
- 3013530341
- 3008460104
- 3008824097
- 3014585508
- 3016592682
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NDC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260910 | EndoTool IV Cloud 1.0 | Glooko, Inc. | 2026-05-01 |
| K253512 | MiniMed Go App | Medtronic Minimed | 2026-01-08 |
| K253281 | UpDoc | Updoc, Inc. | 2025-12-23 |
| K252104 | T1D1 | Comerge AG | 2025-08-20 |
| K241088 | EndoTool IV (3.1) | Monarch Medical Technologies | 2024-12-11 |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | Medtronic Minimed | 2024-11-12 |
| K242066 | iSage Rx | Amalgam Rx, Inc. | 2024-08-21 |
| K232451 | Insulia Bolus Companion | Voluntis Sa. | 2023-12-12 |
| K230813 | BlueStar and BlueStar Rx | Welldoc, Inc. | 2023-07-28 |
| K221924 | Digital Routines | Gnc Holdings, LLC | 2023-03-15 |
| K211160 | EndoTool SubQ 2.1 | Monarch Medical Technologies, LLC | 2021-10-28 |
| K203434 | BlueStar Rx | Welldoc, Inc. | 2021-09-08 |
| K202596 | Insulia Diabetes Management Companion | Voluntis Sa. | 2021-06-04 |
| K201619 | EndoTool IV System | Monarch Medical Technologies, LLC | 2020-08-07 |
| K201337 | InPen System | Companion Medical, Inc. | 2020-06-18 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases