Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cybermed, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
15 daysmedian FDA review time
366 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210039 | CORE1 Implant System | Cybermed, Inc. | 2022-01-07 | 366 | 0 |
| K113543 | ONDEMAND3D | Cybermed, Inc. | 2011-12-16 | 15 | 0 |
| K070464 | ONDEMAND3D | Cybermed, Inc. | 2007-03-16 | 28 | 0 |
| K061126 | ACCUREX | Cybermed, Inc. | 2006-05-09 | 15 | 0 |
| K053155 | VIMPLANT | Cybermed, Inc. | 2005-11-23 | 9 | 0 |
| K013878 | CYBERMED, INC., V-WORKS | Cybermed, Inc. | 2001-12-07 | 14 | 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