Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ellusa, LLC — 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) |
|---|---|---|---|---|---|
| K222429 | Ellusa Reusable Bipolar Cable | Ellusa, LLC | 2022-09-09 | 29 | 0 |
| K222425 | Ellusa Reusable Neutral Plates | Ellusa, LLC | 2022-09-08 | 28 | 0 |
| K202562 | Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, El | Ellusa, LLC | 2020-11-02 | 59 | 0 |
| K202558 | Ellusa Bipolar Wands | Ellusa, LLC | 2020-11-02 | 59 | 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