Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QNM · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
93 daysmedian FDA review time
681 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251761 | Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curv | Momentis Surgical , Ltd. | 2025-07-08 | 29 | 0 |
| K250591 | Anovo Surgical System (6Ne) | Momentis Surgical , Ltd. | 2025-06-06 | 99 | 0 |
| K251056 | Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM | Momentis Surgical , Ltd. | 2025-05-02 | 28 | 0 |
| K243182 | Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM H | Momentis Surgical , Ltd. | 2025-02-03 | 126 | 0 |
| K242157 | Anovo Surgical System (Model 6Ne) | Momentis Surgical , Ltd. | 2024-10-21 | 90 | 0 |
| K241907 | Anovo Surgical System (model 6N) | Momentis Surgical , Ltd. | 2024-10-02 | 93 | 0 |
| K232146 | Anovo Pedestal | Momentis Surgical , Ltd. | 2023-09-14 | 57 | 0 |
| DEN190022 | Hominis Surgical System | Momentis Surgical , Ltd. | 2021-02-26 | 681 | 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