Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EJB · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
285 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140144 | BENDA WEDGE | Centrix, Inc. | 2014-07-08 | 167 | 0 |
| K023367 | DETECTAR, MODEL N123-MI | Neks Technologies | 2003-06-25 | 260 | 0 |
| K981234 | FLARE,FILE, FILL | Lone Star Technologies | 1998-06-05 | 62 | 0 |
| K930094 | AUKUSLEEVE | Aukland Medical Plastics, Inc. | 1993-10-20 | 285 | 0 |
| K922633 | CAVI-ZYME | E&D Dental Products, Inc. | 1992-08-06 | 78 | 0 |
| K871818 | SPATULA, DENTAL, CEMENT | Military Engineering, Inc. | 1987-07-02 | 52 | 0 |
| K833338 | TOOTH SLOOTH | Joel Lander D.D.S. | 1983-11-25 | 59 | 0 |
| K823913 | SOFT GRIP UNI-HANDLE | Treace Medical, Inc. | 1983-01-26 | 29 | 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