Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Mindchild Medical · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161902 | Meridian M110 Fetal Monitoring System | Mindchild Medical | 2017-01-12 | 185 | 0 |
| K142883 | MindChild Meridian M100 Fetal Heart Rate Monitor | Mindchild Medical | 2015-04-17 | 197 | 0 |
| K120018 | MINDCHILD MERIDIAN FETAL HEART RATE MONITOR | Mindchild Medical | 2012-09-19 | 260 | 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