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Tandem Diabetes Care, Inc.

United States·US-MF-000031791

Last updated September 17, 2026

What Tandem Diabetes Care, Inc. makes

Tandem Diabetes Care, Inc. makes ambulatory insulin infusion pumps and related components, including pump systems with software dosing (scalar and binary algorithms), reservoirs, cartridges, administration sets, cartridge filling devices, and integrated systems with blood glucose or interstitial glucose monitoring. Examples include the t:slim X2 Insulin Pump with Control-IQ or Basal-IQ, t:flex Insulin Pump, t:slim Cartridge packs, and t:slim AutoSoft and Mobi Autosoft kits.

The company's devices span Class I, II, and III classifications and Class IIa under EU rules, and are listed in regulatory databases including EUDAMED, FDA 510(k), FDA PMA, and FDA UDI. Tandem Diabetes Care, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of devices does Tandem Diabetes Care, Inc. manufacture?

Tandem Diabetes Care, Inc. manufactures ambulatory insulin infusion pumps and related components, including pump systems with software dosing (scalar and binary algorithms), reservoirs, cartridges, administration sets, cartridge filling devices, and integrated systems with blood glucose or interstitial glucose monitoring, as shown in examples like the t:slim X2 Insulin Pump with Control-IQ or Basal-IQ, t:flex Insulin Pump, t:slim Cartridge packs, and t:slim AutoSoft and Mobi Autosoft kits.

Where is Tandem Diabetes Care, Inc. based?

Tandem Diabetes Care, Inc. is based in the United States, as stated in the SUMMARY section of the provided device data.

In which regulatory registries are Tandem Diabetes Care, Inc.'s devices listed?

Tandem Diabetes Care, Inc.'s devices are listed in EUDAMED, FDA 510(k), FDA PMA, and FDA UDI, as specified in the LISTED IN field of the device data.

How are Tandem Diabetes Care, Inc.'s devices classified under regulatory systems?

Tandem Diabetes Care, Inc.'s devices span Class I, II, and III classifications under U.S. regulations and Class IIa under EU rules, as indicated in the DEVICE CLASSES field.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 12400 High Bluff Drive, San Diego, United States
Website: tandemdiabetes.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 877-801-6901
PRRC Contact: —
EUDAMED SRN: US-MF-000031791
FDA FEI Number: 3013756811
DUNS Number: 827900809

Catalogue (150)

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Device	Model / Reference	Registries	Class	Status
t:slim X2 Insulin Pump with Control-IQ+ Technology	1014073	FDA UDI	Class II	Active
Tandem Mobi Autosoft XC Kit	1015599	FDA UDI	Class II	Active
t:slim X2 Cartridge, t:lock, 10 Pack	1013310	FDA UDI	Class II	Active
t:slim X2 Insulin Pump with Basal-IQ	1006375	FDA UDI	Class II	Active
Tandem Mobi	1013700	FDA UDI	Class II	Active
Tandem Mobi Starter Kit	1013117	FDA UDI	Class II	Active
t:slim X2 Insulin Pump with Basal-IQ	1009639	FDA UDI	Class II	Active
t:slim Cartridge, t:lock, 10 Pack	1000991	FDA UDI	Class II	Active
Tandem Mobi Autosoft XC Kit	1013120	FDA UDI	Class II	Active
t:slim Cartridge, t:lock, 10 Pack	1008619	FDA UDI	Class II	Active
t:slim X2 5.x Insulin Pump	1003808	FDA UDI	Class III	Active
Tandem Mobi Autosoft XC Kit	1014118	FDA UDI	Class II	Active
Tandem Mobi Starter Kit	1014081	FDA UDI	Class II	Active
t:flex Cartridge 10 Pack	004695	FDA UDI	Class II	Active
t:slim X2 5.0 Insulin Pump	1000897	FDA UDI	Class III	Active
Pharmacy Kit, Starter Pack, Tandem T:slim	1017064	FDA UDI	Class II	Active
Sugarmate, Web Application	1008181	EUDAMEDFDA UDI	Class IIa	Active
Tandem Mobi 2 mL Cartridge	1015285	EUDAMED	Class IIa	Active
Control-IQ+ technology	K260429	FDA 510(k)	Class II	Active
T:connect Data Management System	K122361	FDA 510(k)	Class I	Active
Tandem Mobi insulin pump with interoperable technology	K253074	FDA 510(k)	Class II	Active
t:slim X2 insulin pump with interoperable technology	K250792	FDA 510(k)	Class II	Active
t:slim Insulin Delivery System	K160056	FDA 510(k)	Class II	Active
Control-IQ Technology	DEN190034	FDA 510(k)	Class II	Active
Control-IQ Technology	K232382	FDA 510(k)	Class II	Active
t:flex Insulin Delivery System	K143189	FDA 510(k)	Class II	Active
Tandem Mobi insulin pump with interoperable technology	K240309	FDA 510(k)	Class II	Active
T:slim Insulin Delivery System	K133593	FDA 510(k)	Class II	Active
t:slim X2 insulin pump with interoperable technology	DEN180058	FDA 510(k)	Class II	Active
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater	K162080	FDA 510(k)	Class II	Active
T:slim Insulin Delivery System	K141758	FDA 510(k)	Class II	Active
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)	K203234	FDA 510(k)	Class II	Active
Control-IQ+ technology	K243823	FDA 510(k)	Class II	Active
t:slim X2 Insulin Pump with Interoperable Technology	K201214	FDA 510(k)	Class II	Active
Tandem Mobi Insulin Pump with interoperable technology	K241078	FDA 510(k)	Class II	Active
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater	K160482	FDA 510(k)	Class II	Active
Tandem Mobi Insulin Pump with Interoperable Technology	K223213	FDA 510(k)	Class II	Active
T:slim (tm) Insulin Delivery System	K111210	FDA 510(k)	Class II	Active
t:slim X2 Insulin Pump with Interoperable Technology	K232380	FDA 510(k)	Class II	Active
Tandem Mobi insulin pump with interoperable technology	K233044	FDA 510(k)	Class II	Active
Control-IQ Technology	K200467	FDA 510(k)	Class II	Active
Control-IQ+ technology	K250798	FDA 510(k)	Class II	Active
SteadiSet infusion set	K251854	FDA 510(k)	Class II	Active
Sugarmate, Android Mobile Application	1008179	EUDAMED	Class IIa	Active
Tandem Mobi 2 mL Cartridge	1015212	EUDAMED	Class IIa	Active
Sugarmate, iOS Mobile Application	1007228	EUDAMEDFDA UDI	Class IIa	Active
t:slim X2 3mL Cartridge with Sterile Syringe and Needle	1013858	EUDAMED	Class IIa	Active
Tandem Source	1011061	EUDAMEDFDA UDI	Class IIa	Active
t:slim X2 Insulin Pump with Basal-IQ Technology	K193483	FDA PMA	Class III	Active
T:slim G4 Insulin Pump With Dexcom G4 Platinum Cgm System	P140015	FDA PMA	Class III	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (13)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

There are 13 recall records for Tandem Diabetes Care, Inc., with the earliest initiated on 2014-01-10 and the most recent on 2026-01-30. The statuses recorded across these recalls include open, classified, and terminated. The reasons given involve software defects affecting glucose trend interpolation, battery life display inaccuracies, vibration motor malfunctions, mobile app crashes leading to battery drain, insulin cartridge leakage risks, language-specific app defects, translation errors in user guides, speaker-related malfunctions preventing audible alerts, unexpected insulin correction boluses, fuel gauge inaccuracies, and issues with non-volatile memory, touchscreen behavior, and open loop operation.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jan 30, 2026	Z-1636-2026	—	open, classified	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 delivery, potentially leading to a hypoglycemic event.
Oct 6, 2025	Z-0427-2026	—	open, classified	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 result in hyperglycemia.
Aug 5, 2025	Z-0232-2026	—	open, classified	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.
Jul 21, 2025	Z-2343-2025	—	open, classified	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.
Jul 3, 2025	Z-2621-2025	—	open, classified	an app defect that occurs when the phone 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.
Feb 27, 2025	Z-1519-2025	—	open, classified	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 glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
Feb 27, 2025	Z-1520-2025	—	open, classified	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 glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
Mar 5, 2024	Z-1609-2024	—	open, classified	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 suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.
May 24, 2022	Z-1812-2022	—	open, classified	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.
May 24, 2022	Z-1811-2022	—	open, classified	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.
Sep 10, 2020	Z-1258-2022	—	open, classified	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, which could lead to hyperglycemia.
Apr 23, 2018	Z-2471-2018	—	open, classified	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 Alarm 12 (Battery Very Low). The alarms in both scenarios notify the user that the pump has stopped delivering insulin.
Jan 10, 2014	Z-0827-2014	—	terminated	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.