Medical Device Manufacturer · US , San Diego , CA

Tandem Diabetes Care, Inc.

24 submissions · 22 cleared · Since 2011
24
Total
22
Cleared
2
Denied

Tandem Diabetes Care, Inc. — FDA 510(k) Submissions

Tandem Diabetes Care, Inc. has submitted 24 FDA 510(k) premarket notifications since 2011, of which 22 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Alternate Controller Enabled Insulin Infusion Pump, Pump, Infusion, Insulin, Interoperable Automated Glycemic Controller, Medical Device Data System, Interoperable Automated Glycemic Controller, Insulin Suspend . Use the specialty filter in the sidebar to narrow results.

24 devices
1–24 of 24
Tandem Mobi insulin pump with interoperable technology
K253074 · QFG Alternate Controller... · Chemistry
Nov 2025 44d
t:slim X2 insulin pump with interoperable technology
K250792 · QFG Alternate Controller... · Chemistry
Sep 2025 194d
Control-IQ+ technology
K250798 · QJI Interoperable Automated... · Chemistry
May 2025 68d
Control-IQ+ technology
K243823 · QJI Interoperable Automated... · Chemistry
Feb 2025 74d
Tandem Mobi Insulin Pump with interoperable technology
K241078 · QFG Alternate Controller... · Chemistry
Jul 2024 98d
Tandem Mobi insulin pump with interoperable technology
K240309 · QFG Alternate Controller... · Chemistry
Mar 2024 48d
t:slim X2 Insulin Pump with Interoperable Technology
K232380 · QFG Alternate Controller... · Chemistry
Nov 2023 87d
Control-IQ Technology
K232382 · QJI Interoperable Automated... · Chemistry
Nov 2023 87d
Tandem Mobi insulin pump with interoperable technology
K233044 · QFG Alternate Controller... · Chemistry
Oct 2023 10d
Tandem Mobi Insulin Pump with Interoperable Technology
K223213 · QFG Alternate Controller... · Chemistry
Jul 2023 266d
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
K203234 · QFG Alternate Controller... · Chemistry
Feb 2022 469d
Control-IQ Technology
K200467 · QJI Interoperable Automated... · Chemistry
Jun 2020 111d
t:slim X2 Insulin Pump with Interoperable Technology
K201214 · QFG Alternate Controller... · Chemistry
Jun 2020 30d
Basal-IQ Technology
K193483 · QJS Interoperable Automated... · Chemistry
Feb 2020 73d
Control-IQ Technology
DEN190034 · QJI Interoperable Automated... · Chemistry
Dec 2019 151d
t:slim X2 insulin pump with interoperable technology
DEN180058 · QFG Alternate Controller... · Chemistry
Feb 2019 108d
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
K162080 · LZG Pump, Infusion, Insulin · General Hospital
Oct 2016 90d
t:slim Insulin Delivery System
K160056 · LZG Pump, Infusion, Insulin · General Hospital
Jul 2016 195d
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
K160482 · LZG Pump, Infusion, Insulin · General Hospital
Jul 2016 142d
t:flex Insulin Delivery System
K143189 · LZG Pump, Infusion, Insulin · General Hospital
Jan 2015 65d
T:SLIM INSULIN DELIVERY SYSTEM
K141758 · LZG Pump, Infusion, Insulin · General Hospital
Oct 2014 123d
T:SLIM INSULIN DELIVERY SYSTEM
K133593 · LZG Pump, Infusion, Insulin · General Hospital
Mar 2014 122d
T:CONNECT DATA MANAGEMENT SYSTEM
K122361 · OUG Medical Device Data System · General Hospital
Feb 2013 203d
T:SLIM (TM) INSULIN DELIVERY SYSTEM
K111210 · LZG Pump, Infusion, Insulin · General Hospital
Nov 2011 194d
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