Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sturdy Industrial Co., 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) |
|---|---|---|---|---|---|
| K231489 | Sturdy Autoclave Super Microm | Sturdy Industrial Co., Ltd. | 2023-06-21 | 29 | 0 |
| K181993 | STURDY Autoclave Super Microm (models SA-260MA and SA-260MA- | Sturdy Industrial Co., Ltd. | 2019-11-01 | 463 | 0 |
| K032596 | STURDY MANUAL RESUSCITATOR | Sturdy Industrial Co., Ltd. | 2004-08-05 | 349 | 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