Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tandem Diabetes Care, Inc. · Predicate Candidate Screening
25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
203 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260429 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2026-04-24 | 73 | 0 |
| K253074 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2025-11-06 | 44 | 0 |
| K250792 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2025-09-24 | 194 | 1 |
| K250798 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2025-05-21 | 68 | 1 |
| K243823 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2025-02-24 | 74 | 1 |
| K241078 | Tandem Mobi Insulin Pump with interoperable technology | Tandem Diabetes Care, Inc. | 2024-07-26 | 98 | 3 |
| K240309 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2024-03-21 | 48 | 2 |
| K232380 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2023-11-03 | 87 | 3 |
| K232382 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2023-11-03 | 87 | 1 |
| K233044 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2023-10-05 | 10 | 1 |
| K223213 | Tandem Mobi Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2023-07-10 | 266 | 1 |
| K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t | Tandem Diabetes Care, Inc. | 2022-02-15 | 469 | 2 |
| K200467 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2020-06-16 | 111 | 0 |
| K201214 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2020-06-04 | 30 | 2 |
| K193483 | Basal-IQ Technology | Tandem Diabetes Care, Inc. | 2020-02-28 | 73 | 1 |
| DEN190034 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2019-12-13 | 151 | 0 |
| DEN180058 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2019-02-14 | 108 | 0 |
| K162080 | t:slim Insulin Delivery System, t:flex Insulin Delivery Syst | Tandem Diabetes Care, Inc. | 2016-10-25 | 90 | 0 |
| K160056 | t:slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2016-07-25 | 195 | 0 |
| K160482 | t:slim Insulin Delivery System, t:flex Insulin Delivery Syst | Tandem Diabetes Care, Inc. | 2016-07-13 | 142 | 0 |
| K143189 | t:flex Insulin Delivery System | Tandem Diabetes Care, Inc. | 2015-01-09 | 65 | 0 |
| K141758 | T:SLIM INSULIN DELIVERY SYSTEM | Tandem Diabetes Care, Inc. | 2014-10-31 | 123 | 0 |
| K133593 | T:SLIM INSULIN DELIVERY SYSTEM | Tandem Diabetes Care, Inc. | 2014-03-24 | 122 | 0 |
| K122361 | T:CONNECT DATA MANAGEMENT SYSTEM | Tandem Diabetes Care, Inc. | 2013-02-22 | 203 | 0 |
| K111210 | T:SLIM (TM) INSULIN DELIVERY SYSTEM | Tandem Diabetes Care, Inc. | 2011-11-09 | 194 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda