Tandem T: Slim Mobile Application, Android
Catalogue number 1014706, listed by Tandem Diabetes Care, Inc., United States, under Alternate Controller Enabled Insulin Infusion Pump. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
10510(k) clearances naming this product code
8recalls on this code
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
Record
| Listed by | Tandem Diabetes Care, Inc., United States |
|---|---|
| FDA product code | QFG |
| Device type | Alternate Controller Enabled Insulin Infusion Pump |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5730 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K232380 |
| Record published | 2025-03-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1014706 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tandem Mobi Autosoft XC Kit | Tandem Diabetes Care, Inc. | 13 |
| t:slim X2 Insulin Pump with Control-IQ+ Technology | Tandem Diabetes Care, Inc. | 12 |
| t:slim X2 Insulin Pump with Control-IQ | Tandem Diabetes Care, Inc. | 11 |
| t:slim X2 Insulin Pump with Basal-IQ | Tandem Diabetes Care, Inc. | 9 |
| Tandem Mobi | Tandem Diabetes Care, Inc. | 5 |
| MiniMed Flex | Medtronic Minimed | 4 |
| Tandem Mobi Autosoft 30 Kit | Tandem Diabetes Care, Inc. | 4 |
| Omnipod 5 Pod | Insulet Corporation | 3 |
| Tandem Mobi TruSteel Kit | Tandem Diabetes Care, Inc. | 3 |
| Tandem Mobi Cartridge | Tandem Diabetes Care, Inc. | 3 |
| MiniMed Flex Starter Kit | Medtronic, Inc. | 2 |
| Omnipod 5 Controller APP | Insulet Corporation | 2 |
Showing 12 of 36. All products under Alternate Controller Enabled Insulin Infusion Pump
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253074 | 2025-11-06 |
| K250792 | 2025-09-24 |
| K241078 | 2024-07-26 |
| K240309 | 2024-03-21 |
| K232380 | 2023-11-03 |
| K233044 | 2023-10-05 |
| K223213 | 2023-07-10 |
| K203234 | 2022-02-15 |
| K201214 | 2020-06-04 |
| DEN180058 | 2019-02-14 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Tandem Diabetes Care, Inc. | 510(k) number | 2026-01-30 | Class II | Process change control | 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 confir | 1,380 units |
| Tandem Diabetes Care, Inc. | 510(k) number | 2025-07-03 | Class II | Software design | 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. | 19 |
| Tandem Diabetes Care, Inc. | 510(k) number | 2025-02-27 | Class I | Software Design Change | 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 | 63 units |
Recalls
4 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-10-06 | Class I | Software design | 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 | 17,745 |
| 2025-08-05 | Class II | Software change control | 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 insuli | 122,958 |
| 2025-07-21 | Class I | Nonconforming Material/Component | 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, | 171,750 |
| 2025-02-27 | Class I | Software Design Change | 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 | 85 units |
| 2024-03-05 | Class I | Software Design Change | 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 a | 85,863 applications |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.