Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Heroic Faith International , Ltd. · 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) |
|---|---|---|---|---|---|
| K242798 | Airmod | Heroic Faith International , Ltd. | 2025-02-28 | 165 | 0 |
| K242971 | AccurSound Electronic Stethoscope (AS101) | Heroic Faith International , Ltd. | 2024-11-25 | 60 | 0 |
| K221805 | AccurSound Electronic Stethoscope AS-101 | Heroic Faith International , Ltd. | 2023-03-23 | 274 | 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