Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Healstone Biotech, 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) |
|---|---|---|---|---|---|
| K221871 | Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healst | Healstone Biotech, Inc. | 2022-08-30 | 63 | 0 |
| K212418 | hCG One Step Pregnancy Test | Healstone Biotech, Inc. | 2022-06-30 | 331 | 0 |
| K191841 | Accurate Multi Panel Drug Urine Test Cup | Healstone Biotech, Inc. | 2019-08-07 | 29 | 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