Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
QDK · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203089 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM | Dexcom, Inc. | 2021-08-17 | 308 | 0 |
| K193642 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM | Dexcom, Inc. | 2020-01-29 | 30 | 0 |
| K192787 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM | Dexcom, Inc. | 2019-10-25 | 25 | 0 |
| K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring Syst | Dexcom, Inc. | 2018-10-26 | 88 | 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