Basal-IQ Technology
FDA 510(k) clearance K193483 · decided 2020-02-28
Clearance details
- K-number
- K193483
- Device name
- Basal-IQ Technology
- Applicant
- Tandem Diabetes Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-17
- Decision date
- 2020-02-28
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- QJS
- Device class
- 2
- Regulation number
- 862.1356
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:s recall (Z-2343-2025) | Tandem Diabetes Care, Inc. | 2025-08-27 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System (P140015/S029) | Tandem Diabetes Care, Inc. | 2019-12-19 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S007) | Tandem Diabetes Care, Inc. | 2019-12-19 |
| t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System (P140015/S028) | Tandem Diabetes Care, Inc. | 2019-03-01 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S002) | Tandem Diabetes Care, Inc. | 2018-11-29 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S003) | Tandem Diabetes Care, Inc. | 2018-11-29 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S001) | Tandem Diabetes Care, Inc. | 2018-11-29 |
| t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (P140015/S027) | Tandem Diabetes Care, Inc. | 2018-10-26 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S006) | Tandem Diabetes Care, Inc. | 2018-10-26 |