Control-IQ+ technology— 510(k) K250798

Clearance details

Applicant

Tandem Diabetes Care, Inc.

Product code

Code QJI

Device class

Class 2

Regulation

21 CFR 862.1356

Advisory panel

Clinical Chemistry

Date received

2025-03-14

Decision date

2025-05-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Diego, CA, US

• K262763 — iLet Dosing Decision Software2026-09-11
• K261962 — SmartGuard Technology; Predictive Low Glucose Technology2026-07-09
• K261461 — Omnipod 6 algorithm2026-06-29
• K260429 — Control-IQ+ technology2026-04-24
• K253701 — SmartGuard Technology; Predictive Low Glucose Technology2026-02-03

• K253074 — Tandem Mobi insulin pump with interoperable technology2025-11-06
• K250792 — t:slim X2 insulin pump with interoperable technology2025-09-24
• K243823 — Control-IQ+ technology2025-02-24
• K241078 — Tandem Mobi Insulin Pump with interoperable technology2024-07-26
• K240309 — Tandem Mobi insulin pump with interoperable technology2024-03-21

Other

3

Total

3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1636-2026 — Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).Class II·Ongoing·Tandem Diabetes Care, Inc.·20260130

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K250798.