t:flex Insulin Delivery System
FDA 510(k) clearance K143189 · decided 2015-01-09
Clearance details
- K-number
- K143189
- Device name
- t:flex Insulin Delivery System
- Applicant
- Tandem Diabetes Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-11-05
- Decision date
- 2015-01-09
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
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 |