# K193483: Basal-IQ Technology

- Pathway: 510(k) (Traditional)
- Applicant: Tandem Diabetes Care, Inc.
- Decided: Feb 28, 2020 after 73 days
- Product code: QJS (Interoperable Automated Glycemic Controller, Insulin Suspend)
- Device class: 2
- Regulation: 21 CFR 862.1356
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K010362 (2001). 18 ancestors in all.
No later device cites it as a predicate yet.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN190034: Control-IQ Technology, Tandem Diabetes Care, Inc. (2019) Summary page 4.
- K190487: InPen Dose Calculator, Companion Medical, Inc. (2020). Cleared while this submission was under review Summary page 7.

## Recalls of this device
- Jul 21, 2025 · Class I · Z-2343-2025: Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin whic

## Indications for use
Basal-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically suspend delivery of insulin based on iCGM readings and predicted glucose values. Basal-IQ technology is intended for the management of diabetes mellitus in persons six years of age and greater. Basal-IQ technology is intended for single patient use and requires a prescription. Basal-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin. The bolus calculator is indicated for the management of diabetes by people with diabetes by calculating an insulin dose or carbohydrate intake based on user entered data.

Source page: https://510kreport.com/device/K193483
Methodology: https://510kreport.com/methodology