510(k) · Cleared
Recalled · 2026Tandem Mobi insulin pump with interoperable technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tandem Diabetes Care, Inc. · QFG Alternate Controller Enabled Insulin Infusion Pump
Cleared on Nov 6, 2025 as substantially equivalent to K241078 (Tandem Diabetes Care, Inc., 2024) after a 44-day review. Its family tree reaches back 7 generations to 2019. 6 of the 8 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Nov 6, 2025
- Review
- 44 days
- Class
- Class II
- Product code
- QFG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to DEN180058 (2019). No later device cites it as a predicate yet. 6 of the 8 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backDEN180058 t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2019
- 6 generations backK201214 t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2020 · Recalled (Class I)
- 5 generations backK203234 t:slim X2 Insulin Pump with Interoperable Technology (with t:connect…Tandem Diabetes Care, Inc. · 2022 · Recalled (Class I)
- 4 generations backK223213 Tandem Mobi Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023 · Recalled (Class I)
- 3 generations backK233044 Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2023 · Recalled (Class I)
- 2 generations backK240309 Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2024 · Recalled (Class I)
- 1 generation backK241078 Tandem Mobi Insulin Pump with interoperable technologyTandem Diabetes Care, Inc. · 2024 · Recalled (Class I)
- This deviceK253074 Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2025
Class I recalls in this family
- K241078 Tandem Mobi Insulin Pump with interoperable…direct predicate · 2024
- K240309 Tandem Mobi insulin pump with interoperable…2 generations back · 2024
- K233044 Tandem Mobi insulin pump with interoperable…3 generations back · 2023
- K223213 Tandem Mobi Insulin Pump with Interoperable…4 generations back · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN180058 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2019 | — |
| −6 | K201214 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2020 | Class I |
| −5 | K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) | Tandem Diabetes Care, Inc. | 2022 | Class I |
| −4 | K223213 | Tandem Mobi Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2023 | Class I |
| −3 | K233044 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2023 | Class I |
| −2 | K240309 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2024 | Class I |
| −1 | K241078 | Tandem Mobi Insulin Pump with interoperable technology | Tandem Diabetes Care, Inc. | 2024 | Class I |
| 0 (this device) | K253074 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
6 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QFG device
- #1 K251032 MiniMed 780G insulin pumpscore 19.6 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K241078 | Tandem Mobi Insulin Pump with interoperable technologySummary page 5…ate Controller Enabled Infusion Pump Regulation Number 21 CFR 880.5730 Device Class Class II Predicate Device K241078, Tandem Mobi Insulin Pump with interoperable technology I. Device Under Review… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2026 | Not classified | Z-0316-2027 | Process change control | 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… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K241078Tandem Mobi Insulin Pump with interoperable technologyTandem Diabetes Care, Inc. · 2024 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K240309Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2024 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K233044Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2023 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K223213Tandem Mobi Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)Tandem Diabetes Care, Inc. · 2022 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K201214t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2020 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- 6 of the 7 ancestors have a recall of any class; 6 have a Class I recall.
How does its category compare?
All QFG devicesQFG Alternate Controller Enabled Insulin Infusion Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QFG
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QFG
44in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QFG
8so far in 2026, the most since 2007
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · QFG
324,360in 2025
MAUDE reports naming product code QFG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 30,522 |
| 2021 | 0 | — | 0 | 74,701 |
| 2022 | 2 | — | 1 | 129,119 |
| 2023 | 9 | 150 | 1 (1) | 188,014 |
| 2024 | 5 | 89 | 0 | 273,180 |
| 2025 | 5 | 44 | 3 (1) | 324,360 |
| 2026 | 6 | 103 | 8 (1) | — |
What is it indicated for?
The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is intended for…
Read the full statement (199 words)
The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.
The pump is intended for single patient, home use and requires a prescription. The pump is indicated for use in individuals 2 years of age and greater.
Control-IQ+ technology is intended for use with compatible interoperable continuous glucose monitors (iCGM), alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.
Control-IQ+ technology is not a substitute for your own active diabetes management. Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater. Control-IQ+ technology is intended for single patient use and requires a prescription
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253074 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253074: Tandem Mobi insulin pump with interoperable technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253074
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026