Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Asensus Surgical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
226 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233866 | Senhance Surgical System | Asensus Surgical, Inc. | 2024-07-19 | 226 | 0 |
| K223095 | Senhance Surgical System | Asensus Surgical, Inc. | 2023-03-16 | 167 | 1 |
| K220889 | Senhance Surgical System | Asensus Surgical, Inc. | 2022-05-27 | 60 | 0 |
| K212054 | Senhance Surgical System | Asensus Surgical, Inc. | 2021-08-30 | 61 | 0 |
| K211325 | Senhance Surgical System | Asensus Surgical, Inc. | 2021-07-27 | 88 | 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