Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
QJI — Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
111 daysmedian FDA review time
400 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261962 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic MiniMed | 2026-07-09 | 28 | 0 |
| K261461 | Omnipod 6 algorithm | Insulet Corporation | 2026-06-29 | 56 | 0 |
| K260429 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2026-04-24 | 73 | 0 |
| K253701 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic Minimed | 2026-02-03 | 71 | 0 |
| K253585 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | 2026-01-14 | 58 | 0 |
| K251152 | DBLG2 | Diabeloop | 2025-12-19 | 249 | 0 |
| K251779 | Omnipod 5 algorithm | Insulet Corporation | 2025-12-03 | 176 | 0 |
| K251217 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | 2025-08-29 | 130 | 0 |
| 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 |
| K241777 | SmartAdjust™ Technology | Insulet Corporation | 2024-08-26 | 67 | 0 |
| K232741 | SmartAdjust(TM) technology | Insulet Corporation | 2024-05-29 | 265 | 0 |
| K232603 | CamAPS FX | Camdiab , Ltd. | 2024-05-23 | 269 | 0 |
| K234055 | DEKA Loop | Deka Research and Development | 2024-03-13 | 82 | 0 |
| K232382 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2023-11-03 | 87 | 1 |
| K232224 | iLet® Dosing Decision Software | Beta Bionics, Inc. | 2023-09-22 | 57 | 1 |
| K220916 | iLet® Dosing Decision Software | Beta Bionics, Inc. | 2023-05-19 | 415 | 0 |
| K203689 | Tidepool Loop | Tidepool Project | 2023-01-23 | 767 | 0 |
| K220394 | SmartAdjust(TM) technology | Insulet Corporation | 2022-08-19 | 189 | 0 |
| K203774 | SmartAdjust technology | Insulet Corporation | 2022-01-27 | 400 | 0 |
| K200467 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2020-06-16 | 111 | 0 |
| DEN190034 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2019-12-13 | 151 | 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