iSage Rx (iSage Rx Basal Insulin Titration)
FDA 510(k) K161865 · Isag Rx, Inc.
510(k) numberK161865
Submission
- Device name
- iSage Rx (iSage Rx Basal Insulin Titration)
- Applicant
- Isag Rx, Inc.
Wilmington, DE, US - Received
- July 7, 2016
- Decision date
- March 7, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NDC – Calculator, Drug Dose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
Other 510(k)s with product code NDC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254102 | GlucommanderNDC · Traditional | Glytec, LLC | 05/27/2026SE |
| K260910 | EndoTool IV Cloud 1.0NDC · Traditional | Glooko, Inc. | 05/01/2026SE |
| K253512 | MiniMed Go AppNDC · Traditional | Medtronic Minimed | 01/08/2026SE |
| K253281 | UpDocNDC · Traditional | Updoc, Inc. | 12/23/2025SE |
| K252104 | T1D1NDC · Traditional | Comerge AG | 08/20/2025SE |
| K241088 | EndoTool IV (3.1)NDC · Traditional | Monarch Medical Technologies | 12/11/2024SE |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android))NDC · Traditional | Medtronic Minimed | 11/12/2024SE |
| K242066 | iSage RxNDC · Traditional | Amalgam Rx, Inc. | 08/21/2024SE |
| K232451 | Insulia Bolus CompanionNDC · Traditional | Voluntis Sa. | 12/12/2023SE |
| K230813 | BlueStar and BlueStar RxNDC · Traditional | Welldoc, Inc. | 07/28/2023SE |
Questions and answers
When was iSage Rx (iSage Rx Basal Insulin Titration) cleared by the FDA?
iSage Rx (iSage Rx Basal Insulin Titration) (K161865) received a 510(k) decision of Substantially Equivalent on March 7, 2017, 243 days after the submission was received.
What is the product code of K161865?
The FDA product code is NDC – Calculator, Drug Dose, a Class II (moderate risk) device regulated under 21 CFR 868.1890.