T:SLIM INSULIN DELIVERY SYSTEM
FDA 510(k) clearance K141758 · decided 2014-10-31
Clearance details
- K-number
- K141758
- Device name
- T:SLIM INSULIN DELIVERY SYSTEM
- Applicant
- Tandem Diabetes Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-06-30
- Decision date
- 2014-10-31
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Philedelphia, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Tandem Diabetes Care
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |