Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QLG — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
215 daysmedian FDA review time
396 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222280 | Bigfoot Unity® Diabetes Management System | Bigfoot Biomedical, Inc. | 2023-03-01 | 215 | 0 |
| K223537 | FreeStyle Libre 2 System, FreeStyle Libre 3 System | Abbott Diabetes Care, Inc. | 2023-02-21 | 90 | 0 |
| K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2022-05-26 | 322 | 3 |
| K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2022-05-26 | 157 | 1 |
| K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with Free | Abbott Diabetes Care, Inc. | 2021-11-22 | 237 | 0 |
| K211102 | FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2021-08-11 | 120 | 0 |
| K201761 | FreeStyle Libre 2 Flash Glucose Monitoring System (with Free | Abbott Diabetes Care, Inc. | 2021-07-30 | 396 | 0 |
| K202145 | Bigfoot Unity Diabetes Management System | Bigfoot Biomedical, Inc. | 2021-05-07 | 280 | 1 |
| K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2020-06-12 | 190 | 2 |
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