Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Molli Surgical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
148 daysmedian FDA review time
272 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K234149 | MOLLI 2 System | Molli Surgical, Inc. | 2024-09-26 | 272 | 0 |
| K240042 | MOLLI 2 System | Molli Surgical, Inc. | 2024-09-25 | 264 | 0 |
| K231579 | MOLLI 2 | Molli Surgical, Inc. | 2023-10-26 | 148 | 1 |
| K223107 | MOLLI 2 | Molli Surgical, Inc. | 2023-01-18 | 110 | 0 |
| K210600 | MOLLI | Molli Surgical, Inc. | 2021-04-16 | 46 | 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