Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rockwin Corp. · 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) |
|---|---|---|---|---|---|
| K974129 | HI-69E, HI-69N, HI-69P | Rockwin Corp. | 1997-12-12 | 39 | 0 |
| K943808 | RIONET HM-02 | Rockwin Corp. | 1995-05-24 | 293 | 0 |
| K935559 | HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000 | Rockwin Corp. | 1994-01-27 | 71 | 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