Tandem Diabetes Care, Inc. · Class II · Cleared Apr 24, 2026
| K-number | K260429 |
| Device name | Control-IQ+ technology |
| Applicant | Tandem Diabetes Care, Inc. |
| Product code | QJI |
| Device class | Class II |
| Decision date | Apr 24, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 862.1356 |
Control-IQ+ technology is a software-only automated insulin delivery system that controls basal insulin delivery from compatible insulin pumps based on continuous glucose monitor readings and user inputs. It is intended for managing Type 1 diabetes in persons 2 years and older and Type 2 diabetes in persons 18 years and older, including use in pregnancy with Type 1 diabetes, and requires a prescription.
The subject device is identical to the predicate device (K250798) in all tested technological characteristics, including pump type, compatible insulins, basal rate ranges, automatic correction boluses, body weight settings, extended bolus duration, and temporary basal rate functionality. The primary difference is the addition of a pregnancy indication for Type 1 diabetes, provided the linked CGM system is suitable for pregnancy use.
Not stated in this summary.
The subject device performs the same insulin therapy functions as the predicate device with identical technical specifications across all measured parameters. No new software, usability, insulin compatibility, or biocompatibility testing was required because the device maintains all predicate device characteristics. A clinical study (CIRCUIT) demonstrated safety and effectiveness in pregnancy, supporting the new pregnancy indication while maintaining substantial equivalence to the predicate.
View the full FDA submission: accessdata.fda.gov