Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtronic Minimed, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
392 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| 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 |
| K253585 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | 2026-01-14 | 58 | 0 |
| K251217 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | 2025-08-29 | 130 | 0 |
| K251032 | MiniMed 780G insulin pump | Medtronic Minimed, Inc. | 2025-07-01 | 89 | 4 |
| K210714 | Extended Reservoir | Medtronic Minimed, Inc. | 2022-04-06 | 392 | 0 |
| K151236 | MiniMed Connect kit, MiniMed Connect uploader, MiniMed Conne | Medtronic Minimed, Inc. | 2015-05-19 | 8 | 0 |
| K070438 | MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 | Medtronic Minimed, Inc. | 2007-10-17 | 244 | 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