Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ag Digital Technology Corp. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121453 | A-GRIX TE RESORABLE BONE VOID FILLER | Ag Digital Technology Corp. | 2013-02-05 | 265 | 0 |
| K101641 | AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 | Ag Digital Technology Corp. | 2011-06-16 | 371 | 0 |
| K091688 | A-GRIX RESORBABLE BONE VOID FILLER | Ag Digital Technology Corp. | 2010-03-02 | 265 | 0 |
| K083279 | CALTRIX RESORBABLE BONE VOID FILLER | Ag Digital Technology Corp. | 2009-01-28 | 82 | 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