Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Deep Blue Medical Advances, Inc. · 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) |
|---|---|---|---|---|---|
| K232924 | T-Line® Hernia Mesh | Deep Blue Medical Advances, Inc. | 2023-10-18 | 29 | 0 |
| K230227 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2023-02-23 | 27 | 0 |
| K221556 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2022-11-28 | 181 | 0 |
| K193144 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2020-03-30 | 138 | 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