Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MOV — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
851 daysmedian FDA review time
911 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180552 | Modified Novy Cornual Cannulation Set | Cook Incorporated | 2018-07-12 | 133 | 0 |
| K932436 | ECHOMARK INTRAUTERINE GUIDING CATHETER | Echocath, Inc. | 1995-11-16 | 911 | 0 |
| K931534 | OVAMED INTRAUTERINE ACCESS CATHETER | Ovamed Corp. | 1995-07-28 | 851 | 0 |
| K931476 | NOVY CORNUAL CANNULATION SET | Cook Ob/Gyn | 1995-07-28 | 856 | 3 |
| K953314 | CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM | Conceptus, Inc. | 1995-07-28 | 16 | 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