FDA 510(k) Applications Submitted by Tandem Diabetes Care, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K201214 |
05/05/2020 |
t:slim X2 Insulin Pump with Interoperable Technology |
Tandem Diabetes Care, Inc. |
| K203234 |
11/03/2020 |
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) |
Tandem Diabetes Care, Inc. |
| K223213 |
10/17/2022 |
Tandem Mobi Insulin Pump with Interoperable Technology |
Tandem Diabetes Care, Inc. |
| K111210 |
04/29/2011 |
T:SLIM (TM) INSULIN DELIVERY SYSTEM |
TANDEM DIABETES CARE, INC. |
| K122361 |
08/03/2012 |
T:CONNECT DATA MANAGEMENT SYSTEM |
TANDEM DIABETES CARE, INC. |
| K141758 |
06/30/2014 |
T:SLIM INSULIN DELIVERY SYSTEM |
TANDEM DIABETES CARE, INC. |
| K143189 |
11/05/2014 |
t:flex Insulin Delivery System |
Tandem Diabetes Care, Inc. |
| K133593 |
11/22/2013 |
T:SLIM INSULIN DELIVERY SYSTEM |
TANDEM DIABETES CARE, INC. |
| K160056 |
01/12/2016 |
t:slim Insulin Delivery System |
Tandem Diabetes Care, Inc. |
| K160482 |
02/22/2016 |
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater |
Tandem Diabetes Care, Inc. |
| K200467 |
02/26/2020 |
Control-IQ Technology |
Tandem Diabetes Care, Inc. |
| DEN190034 |
07/15/2019 |
Control-IQ Technology |
Tandem Diabetes Care, Inc. |
| K162080 |
07/27/2016 |
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater |
Tandem Diabetes Care, Inc. |
| DEN180058 |
10/29/2018 |
t:slim X2 insulin pump with interoperable technology |
Tandem Diabetes Care, Inc. |
| K193483 |
12/17/2019 |
Basal-IQ Technology |
Tandem Diabetes Care, Inc. |
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