Data / Medical devices / United States / Tandem Diabetes Care, Inc.

Tandem Diabetes Care, Inc.: FDA-registered device maker in San Diego, CA, United States, 21 510(k) clearances and 2 PMA approvals

Name: Tandem Diabetes Care, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Tandem Diabetes Care, Inc. is registered with the FDA (registration 3007981285) in San Diego, CA, United States. It lists 14 device types. The FDA files 21 510(k) clearances and 2 PMA approvals under its listings, the newest dated April 24, 2026. 13 recall events name it as the recalling firm (5 Class I). Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3007981285
Address: 12400 High Bluff Drive, San Diego, CA, United States, 92130
Owner or operator: Tandem Diabetes Care, Inc. (10039506)
Roles: Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
First device listed: January 16, 2012
Registered through: 2027
Brand names listed: Alternate Controller Enabled Insulin Infusion Pump, Control-IQ Technology, Interoperable Automated Glycemic Controller, Sugarmate Platform, Sugarmate Platform; Sugarmate, Alexa Skill Application; Sugarmate, Android Mobile Application; Sugarmate, iOS Mobile App, T:slim X2 Insulin Pump, Tandem Device Updater, Tandem Mobi Adhesive Sleeve and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Pump, Infusion	MRZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Alternate Controller Enabled Insulin Infusion Pump	QFG	2	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Automated Insulin Dosing , Threshold Suspend	OZO	3	Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
Calculator, Drug Dose	NDC	2	Manufacturer, Remanufacturer	accessdata.fda.gov
Continuous Glucose Monitor Retrospective Data Analysis Software	PHV	1	Manufacturer	accessdata.fda.gov
Continuous Glucose Monitor Secondary Display	PJT	2	Manufacturer	accessdata.fda.gov
Insulin Pump Secondary Display	PKU	2	Manufacturer	accessdata.fda.gov
Interoperable Automated Glycemic Controller	QJI	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Interoperable Automated Glycemic Controller, Insulin Suspend	QJS	2	Manufacturer, Remanufacturer	accessdata.fda.gov
Pump, Infusion, Insulin	LZG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor	OYC	3	Complaint file establishment, Specification developer	accessdata.fda.gov
Sensor, Glucose, Invasive	MDS	3	Complaint file establishment, Specification developer	accessdata.fda.gov
Sensor, Glucose, Invasive, Non-Adjunctive	PQF	3	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 24, 2026	K260429	Control-IQ+ technology	QJI	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
November 6, 2025	K253074	Tandem Mobi insulin pump with interoperable technology	QFG	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
September 24, 2025	K250792	t:slim X2 insulin pump with interoperable technology	QFG	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
May 21, 2025	K250798	Control-IQ+ technology	QJI	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
July 26, 2024	K241078	Tandem Mobi Insulin Pump with interoperable technology	QFG	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
March 21, 2024	K240309	Tandem Mobi insulin pump with interoperable technology	QFG	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
November 3, 2023	K232382	Control-IQ Technology	QJI	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
November 3, 2023	K232380	t:slim X2 Insulin Pump with Interoperable Technology	QFG	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
July 10, 2023	K223213	Tandem Mobi Insulin Pump with Interoperable Technology	QFG	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
February 15, 2022	K203234	t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)	QFG	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
June 16, 2020	K200467	Control-IQ Technology	QJI	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
June 4, 2020	K201214	t:slim X2 Insulin Pump with Interoperable Technology	QFG	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
February 28, 2020	K193483	Basal-IQ Technology	QJS	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
December 13, 2019	DEN190034	Control-IQ Technology	QJI	Unknown	Tandem Diabetes Care, Inc.	accessdata.fda.gov
February 14, 2019	DEN180058	t:slim X2 insulin pump with interoperable technology	QFG	Unknown	Tandem Diabetes Care, Inc.	accessdata.fda.gov
October 25, 2016	K162080	t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater	LZG	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
July 25, 2016	K160056	t:slim Insulin Delivery System	LZG	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
January 9, 2015	K143189	t:flex Insulin Delivery System	LZG	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
October 31, 2014	K141758	T:SLIM INSULIN DELIVERY SYSTEM	LZG	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
March 24, 2014	K133593	T:SLIM INSULIN DELIVERY SYSTEM	LZG	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov
November 9, 2011	K111210	T:SLIM (TM) INSULIN DELIVERY SYSTEM	LZG	Substantially Equivalent	Tandem Diabetes Care, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
June 21, 2018	P180008	t:slim X2 Insulin Pump with Basal-IQ Technology	OZO	6	December 19, 2019	accessdata.fda.gov
September 8, 2015	P140015	T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM	OYC	29	December 19, 2019	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 23, 2026	99851	Not yet classified	Open, Classified	Tandem Mobi Insulin Pump, Models: 1004004, 1010750, 1012676, 1012719, 1013655, 1013656, 1013501, 1013700, 1014081, 1014801, 1014811, 1014813, 1014936, 1016911, 1016912, 1016913, 1016914, 1018075, 1018077, 1018078	Tandem Diabetes Care, Inc. ( Tandem ) has identified that certain Tandem Mobi insulin pumps may generate false-positive occlusion alarms when no actual insulin flow obstruction is present. Investigation determined that increased friction within the drive module can reduce available motor power and, under certain conditions, cause motor speed to fall below th	accessdata.fda.gov
July 16, 2026	99589	Class II	Ongoing	Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 00389152470740 Component: No	A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose monitoring (CGM) sensors, resulting in the insulin pump being unable to establish a near-field communication (NFC) connection with the CGM a	accessdata.fda.gov
January 30, 2026	98478	Class II	Ongoing	Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion	The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin deliv	accessdata.fda.gov
October 6, 2025	97662	Class I	Ongoing	Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin f	Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped", which could	accessdata.fda.gov
August 5, 2025	97403	Class II	Ongoing	t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, C	A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.	accessdata.fda.gov
July 21, 2025	97003	Class I	Ongoing	Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Us	Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.	accessdata.fda.gov
July 3, 2025	97264	Class II	Ongoing	t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)	an app defect that occurs when the is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia.	accessdata.fda.gov
February 27, 2025	96417	Class I	Ongoing	t:slim X2 Insulin Pump with Interoperable Technology	A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous g	accessdata.fda.gov
March 5, 2024	94312	Class I	Ongoing	t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology	During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspe	accessdata.fda.gov
May 24, 2022	90628	Class II	Ongoing	t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology	Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a software update. Issues could result in hypoglycemia, hyperglycemia or diabetic ketoacidosis.	accessdata.fda.gov
September 10, 2020	90113	Class II	Ongoing	t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology	Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop	accessdata.fda.gov
April 23, 2018	79887	Class II	Ongoing	t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.	The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide inaccurate readings, which present to the user in one of two ways: A) by triggering a Malfunction 4 Alarm, or B) by triggering a succession of notifications prior to the pump shutting off, including Alert 2 (Battery Low), Alert 3 (Battery Very Low) and Alar	accessdata.fda.gov
January 10, 2014	67264	Class I	Terminated	T:slim Insulin Delivery System Insulin Infusion Pump	Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A cartridge leak could result in the device delivering too much or too little insulin, which can lead to a serious adverse event.	accessdata.fda.gov

Compare with other makers

Updated October 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.