t:slim X2 Insulin Pump with Interoperable Technology— 510(k) K232380
Substantially EquivalentTandem Diabetes Care, Inc.
FDA 510(k) clearance K232380 for t:slim X2 Insulin Pump with Interoperable Technology, Substantially Equivalent on 2023-11-03. Applicant: Tandem Diabetes Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Tandem Diabetes Care, Inc.
- Product code
- Code QFG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5730
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code QFG
view allMore clearances from Tandem Diabetes Care, Inc.
view allAdverse events under product code QFG
product code QFG- Death
- 228
- Injury
- 118,915
- Malfunction
- 1,001,752
- Other
- 7
- Total
- 1,120,902
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 →
Recalls naming K232380
K-number listed on FDA's recall record- 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).
- Z-2621-2025 — t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
- Z-1519-2025 — t:slim X2 Insulin Pump with Interoperable Technology
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232380.
Data sourced from openFDA. This site is unofficial and independent of the FDA.