Health-e-Connect System with IDA
510(k) K163664
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163664 | Date18 Sep 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NDC
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1890
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Health-e-Connect System with IDA is a Calculator, Drug Dose device (FDA regulation 868.1890) designed for remote monitoring and calculation of insulin doses. It processes patient blood glucose data, including historical test results from glucose meters, to generate reference insulin dose recommendations based on clinical guidelines from the American Association of Clinical Endocrinologists (AACE) and the American Diabetes Association (ADA).
This web-based software platform is intended for use in anesthesiology settings, though its primary function is not directly tied to intraoperative procedures. Supplied as a reusable digital system, it does not require sterilization or single-use compliance. The device operates under FDA 510(k) clearance (K163664) and is classified as a Class II medical device. No MRI safety or physical size specifications are provided in the regulatory data.
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Questions
AI-generated answers, 1 Oct 2026
What is the Health-e-Connect System with IDA used for?
The Health-e-Connect System with IDA is a digital calculator designed to assist in determining insulin doses for patients. It processes blood glucose data—including historical results from compatible glucose meters—and generates reference dose recommendations based on clinical guidelines from the American Association of Clinical Endocrinologists (AACE) and the American Diabetes Association (ADA). It is not intended for intraoperative use in anesthesiology but supports remote monitoring and decision-making in diabetes management.
How is the Health-e-Connect System with IDA supplied and maintained?
This device is supplied as a reusable digital system, meaning it is not single-use or disposable. Since it is a software-based platform, it does not require sterilization or physical cleaning like traditional medical devices. Maintenance involves ensuring the system’s software is up-to-date and that patient data is securely managed in compliance with healthcare regulations.
Does the Health-e-Connect System with IDA require sterilization or have physical size specifications?
No, the Health-e-Connect System with IDA does not require sterilization because it is a reusable digital system with no physical components that would necessitate sterilization procedures. The regulatory data does not provide specific physical size specifications for the device, as its functionality is entirely software-based and web-hosted.
What regulatory approval does the Health-e-Connect System with IDA hold?
The Health-e-Connect System with IDA holds FDA 510(k) clearance under the classification of a Class II medical device. This clearance (K163664) confirms that the device is substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness as a calculator for drug dose recommendations.
Can the Health-e-Connect System with IDA integrate with other glucose monitoring devices?
The device processes patient blood glucose data from glucose meters, implying compatibility with meters that can transmit results to the Health-e-Connect System. However, the exact models or brands of compatible meters are not specified in the regulatory data. Clinicians or users should verify compatibility with their specific glucose monitoring equipment before integration.