Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stayhealthy, Inc. · 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) |
|---|---|---|---|---|---|
| K123539 | STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK | Stayhealthy, Inc. | 2013-04-22 | 157 | 0 |
| K101807 | STAYHEALTHY BODY COMPOSITION MONITOR-BCM | Stayhealthy, Inc. | 2011-01-26 | 212 | 0 |
| K052522 | STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2 | Stayhealthy, Inc. | 2005-12-13 | 90 | 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