Tandem Diabetes Care, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Control-IQ+ technology, Tandem Mobi insulin pump with interoperable technology, t:slim X2 insulin pump with interoperable technology
25
Total
23
Cleared
2
Denied
FDA 510(k) Regulatory Record - Tandem Diabetes Care, Inc. Chemistry ✕
17 devices
Cleared
CT
Apr 24, 2026
Control-IQ+ technology
Chemistry
73d
Cleared
Nov 06, 2025
Tandem Mobi insulin pump with interoperable technology
Chemistry
44d
Cleared
Sep 24, 2025
t:slim X2 insulin pump with interoperable technology
Chemistry
194d
Cleared
CT
May 21, 2025
Control-IQ+ technology
Chemistry
68d
Cleared
CT
Feb 24, 2025
Control-IQ+ technology
Chemistry
74d
Cleared
Jul 26, 2024
Tandem Mobi Insulin Pump with interoperable technology
Chemistry
98d
Cleared
Mar 21, 2024
Tandem Mobi insulin pump with interoperable technology
Chemistry
48d
Cleared
Nov 03, 2023
t:slim X2 Insulin Pump with Interoperable Technology
Chemistry
87d
Cleared
CT
Nov 03, 2023
Control-IQ Technology
Chemistry
87d
Cleared
Oct 05, 2023
Tandem Mobi insulin pump with interoperable technology
Chemistry
10d
Cleared
Jul 10, 2023
Tandem Mobi Insulin Pump with Interoperable Technology
Chemistry
266d
Cleared
Feb 15, 2022
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
Chemistry
469d
Cleared
CT
Jun 16, 2020
Control-IQ Technology
Chemistry
111d
Cleared
Jun 04, 2020
t:slim X2 Insulin Pump with Interoperable Technology
Chemistry
30d
Cleared
Feb 28, 2020
Basal-IQ Technology
Chemistry
73d
Not Cleared
Dec 13, 2019
Control-IQ Technology
Chemistry
151d
Not Cleared
Feb 14, 2019
t:slim X2 insulin pump with interoperable technology
Chemistry
108d