Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
SAQ · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
111 daysmedian FDA review time
346 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252287 | Symani Surgical System | Medical Microinstruments, Inc. | 2025-11-10 | 110 | 0 |
| K251510 | Symani Surgical System | Medical Microinstruments, Inc. | 2025-09-04 | 111 | 0 |
| K242368 | Symani Surgical System | Medical Microinstruments, Inc. | 2025-02-07 | 182 | 0 |
| K250014 | Symani Surgical System (820-03830) | Medical Microinstruments, Inc. | 2025-01-27 | 25 | 0 |
| DEN230032 | Symani Surgical System | Mmi North America, Inc. | 2024-04-05 | 346 | 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