Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QFG — Predicate Candidate Screening
28 FDA 510(k) clearances under this product code; the 50 most recent screened below.
98 daysmedian FDA review time
469 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261672 | twiist Automated Insulin Delivery (AID) System | Deka Research and Development | 2026-06-17 | 27 | 0 |
| K253976 | iLet ACE Pump | Beta Bionics, Inc. | 2026-04-30 | 139 | 0 |
| K253743 | MiniMed Flex pump | Medtronic Minimed, Inc. | 2026-03-12 | 108 | 0 |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin P | Medtronic Minimed, Inc. | 2026-01-15 | 97 | 0 |
| K253074 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2025-11-06 | 44 | 0 |
| K252770 | iLet ACE Pump | Beta Bionics, Inc. | 2025-09-29 | 27 | 2 |
| K250792 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2025-09-24 | 194 | 1 |
| K251032 | MiniMed 780G insulin pump | Medtronic Minimed, Inc. | 2025-07-01 | 89 | 4 |
| K250930 | twiist system | Deka Research & Development Corp. | 2025-04-02 | 5 | 0 |
| K234027 | embecta Insulin Delivery System | Embecta Medical I, LLC | 2024-08-30 | 254 | 0 |
| K241078 | Tandem Mobi Insulin Pump with interoperable technology | Tandem Diabetes Care, Inc. | 2024-07-26 | 98 | 3 |
| K241178 | DEKA ACE Pump System | Deka Research and Development | 2024-05-24 | 25 | 0 |
| K240309 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2024-03-21 | 48 | 2 |
| K233952 | DEKA ACE Pump System | Deka Research and Development | 2024-03-13 | 89 | 0 |
| K230545 | Inessa System | Triple Jump Israel , Ltd. | 2023-12-20 | 295 | 0 |
| K232380 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2023-11-03 | 87 | 3 |
| K231826 | Omnipod 5 ACE Pump | Insulet Corporation | 2023-10-18 | 119 | 5 |
| K233044 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2023-10-05 | 10 | 1 |
| K213134 | Accu-Chek Solo micropump system with interoperable technolog | Roche Diabetes Care GmbH | 2023-08-10 | 682 | 0 |
| K213536 | DEKA ACE Pump System | Deka Research and Development | 2023-07-25 | 627 | 0 |
| K223213 | Tandem Mobi Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2023-07-10 | 266 | 1 |
| K231485 | iLet® ACE Pump | Beta Bionics, Inc. | 2023-06-21 | 29 | 1 |
| K223846 | iLet® ACE Pump | Beta Bionics, Inc. | 2023-05-19 | 150 | 0 |
| K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t | Tandem Diabetes Care, Inc. | 2022-02-15 | 469 | 2 |
| K203768 | Omnipod 5 ACE Pump (Pod) | Insulet Corporation | 2022-01-27 | 400 | 2 |
| K201214 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2020-06-04 | 30 | 2 |
| K191679 | Omnipod DASH Insulin Management System with interoperable te | Insulet Corporation | 2019-09-20 | 88 | 0 |
| DEN180058 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2019-02-14 | 108 | 0 |
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