Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Infant Advantage, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
338 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970334 | NATURE'S CRADLE | Infant Advantage, Inc. | 1997-04-25 | 87 | 0 |
| K960747 | NATURE'S CRADLE MODEL C1500 | Infant Advantage, Inc. | 1996-05-22 | 89 | 0 |
| K951024 | NATURE'S CRADLE | Infant Advantage, Inc. | 1995-06-05 | 91 | 0 |
| K921327 | NATURE'S CRADLE HM-10 | Infant Advantage, Inc. | 1992-12-29 | 286 | 0 |
| K901763 | NATURE'S CRADLE(TM) | Infant Advantage, Inc. | 1991-03-22 | 338 | 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