Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Applied Diabetes Research, Incorporated — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033099 | ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-1 | Applied Diabetes Research, Incorporated | 2003-10-16 | 17 | 0 |
| K024056 | SURESET 3.0 ML RESERVOIR, MODEL 24-103 | Applied Diabetes Research, Incorporated | 2003-01-17 | 39 | 0 |
| K012429 | SURESET INFUSION SET, MODEL 8023 | Applied Diabetes Research, Incorporated | 2001-11-06 | 98 | 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