Control-IQ+ technology— 510(k) K260429
Substantially EquivalentTandem Diabetes Care, Inc.
FDA 510(k) clearance K260429 for Control-IQ+ technology, Substantially Equivalent on 2026-04-24. Applicant: Tandem Diabetes Care, Inc.. Device class: 2.
Summary
Tandem Diabetes Care's Control-IQ+ technology is filed under product code QJI (Interoperable Automated Glycemic Controller). The record doesn't describe the technology beyond its name and that code name.
Class II, 21 CFR 862.1356. It came in as a Traditional 510(k), and Clinical Chemistry is both the classification panel and the review panel.
Tandem Diabetes Care filed from San Diego, California. Review took 73 calendar days (February 10 to April 24, 2026).
Clearance details
- Applicant
- Tandem Diabetes Care, Inc.
- Product code
- Product code QJI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1356
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code QJI
view allMore clearances from Tandem Diabetes Care, Inc.
view allAdverse events under product code QJI
product code QJI- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.