# K163664: Health-e-Connect System with IDA

- Pathway: 510(k) (Traditional)
- Applicant: Alr Technologies
- Decided: Sep 18, 2017 after 265 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K864318 (1987). 76 ancestors in all.
No later device cites it as a predicate yet.
1 of 77 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082512: Intelligent Dosing System for Insulin-MY Insulin Doser, Dimensional Dosing Systems, Inc. (2008) Summary page 4.
- K011571: TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite, The RX Files Corp. (2001) Summary page 4.
- K102063: Health-E-Connect System, Alr Technologies (2011) Summary page 4.

## Indications for use
The Health-e-Connect System with IDA is intended for use in the home and clinical settings by people with diabetes and healthcare providers as an aid in the review, analysis, and evaluation of historical glucose test results and associated usage data in support of an effective diabetes management program. The Insulin Dose Adjustment (IDA) feature is intended only for insulin-requiring Type 2 diabetes patients to provide the physician with two reference doses. The IDA feature is not indicated for patients who utilize insulin pumps and it is limited to adults with Type 2 diabetes on fixed dose regimen of insulin. The Health-e-Connect System with IDA is for patients under the supervision of a physician / healthcare provider trained in the management of diabetes. Final drug dose recommendations for a patient must be made only after careful consideration of the full clinical status of the patient. No medical decision should be based solely upon the results provided by this software program.

Source page: https://510kreport.com/device/K163664
Methodology: https://510kreport.com/methodology