Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
SAF — 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) |
|---|---|---|---|---|---|
| K261359 | Stelo Glucose Biosensor System | Dexcom, Inc. | 2026-05-21 | 27 | 0 |
| K250106 | Signos Glucose Monitoring System | Signos, Inc. | 2025-03-21 | 65 | 0 |
| K233655 | Lingo Glucose System | Abbott | 2024-05-29 | 197 | 0 |
| K234070 | Stelo Glucose Biosensor System | Dexcom, Inc. | 2024-03-05 | 74 | 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