Tandem Mobi insulin pump with interoperable technology
FDA 510(k) clearance K240309 · decided 2024-03-21
Clearance details
- K-number
- K240309
- Device name
- Tandem Mobi insulin pump with interoperable technology
- Applicant
- Tandem Diabetes Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-02-02
- Decision date
- 2024-03-21
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- QFG
- Device class
- 2
- Regulation number
- 880.5730
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Tandem Diabetes Care
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| twiist Automated Insulin Delivery (AID) System (K261672) | Deka Research and Development | 2026-06-17 |
| iLet ACE Pump (K253976) | Beta Bionics, Inc. | 2026-04-30 |
| MiniMed Flex pump (K253743) | Medtronic Minimed, Inc. | 2026-03-12 |
| MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) (K253470) | Medtronic Minimed, Inc. | 2026-01-15 |
| Tandem Mobi insulin pump with interoperable technology (K253074) | Tandem Diabetes Care, Inc. | 2025-11-06 |
| iLet ACE Pump (K252770) | Beta Bionics, Inc. | 2025-09-29 |
| t:slim X2 insulin pump with interoperable technology (K250792) | Tandem Diabetes Care, Inc. | 2025-09-24 |
| MiniMed 780G insulin pump (K251032) | Medtronic Minimed, Inc. | 2025-07-01 |
| twiist system (K250930) | Deka Research & Development Corp. | 2025-04-02 |
| embecta Insulin Delivery System (K234027) | Embecta Medical I, LLC | 2024-08-30 |
| Tandem Mobi Insulin Pump with interoperable technology (K241078) | Tandem Diabetes Care, Inc. | 2024-07-26 |
| DEKA ACE Pump System (K241178) | Deka Research and Development | 2024-05-24 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated i recall (Z-0427-2026) | Tandem Diabetes Care, Inc. | 2025-11-05 |
| t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070 recall (Z-0232-2026) | Tandem Diabetes Care, Inc. | 2025-10-23 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System (P140015/S029) | Tandem Diabetes Care, Inc. | 2019-12-19 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S007) | Tandem Diabetes Care, Inc. | 2019-12-19 |
| t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System (P140015/S028) | Tandem Diabetes Care, Inc. | 2019-03-01 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S002) | Tandem Diabetes Care, Inc. | 2018-11-29 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S003) | Tandem Diabetes Care, Inc. | 2018-11-29 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S001) | Tandem Diabetes Care, Inc. | 2018-11-29 |
| t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (P140015/S027) | Tandem Diabetes Care, Inc. | 2018-10-26 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S006) | Tandem Diabetes Care, Inc. | 2018-10-26 |