t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)— 510(k) K203234
Substantially EquivalentTandem Diabetes Care, Inc.
FDA 510(k) clearance K203234 for t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app), Substantially Equivalent on 2022-02-15. 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 K203234
K-number listed on FDA's recall record- Z-0232-2026 — t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and User Guide when using Dexcom G7 sensor
- Z-1609-2024 — t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203234.
Data sourced from openFDA. This site is unofficial and independent of the FDA.