Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FIG · 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) |
|---|---|---|---|---|---|
| K093915 | DEKA TAC DEVICE | Deka Research & Development Corp. | 2011-08-23 | 609 | 0 |
| K921993 | ELS AUTOMATIC TUBING CLAMP SYSTEM | Rocky Mountain Research, Inc. | 1994-01-05 | 617 | 0 |
| K914459 | AUTOMATIC TUBING CLAMP | Rocky Mountain Research, Inc. | 1992-06-24 | 261 | 0 |
| K770535 | C-DAK 3500 | Cordis Corp. | 1977-04-15 | 25 | 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