Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Blade Works, 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) |
|---|---|---|---|---|---|
| K020079 | BLADEWORKS MICROKERATOME BLADE, MODEL 7061 | Blade Works, Inc. | 2002-04-19 | 99 | 0 |
| K993225 | BLADEWORKS MICROKERATOME BLADE | Blade Works, Inc. | 2000-03-20 | 175 | 0 |
| K993591 | BLADEWORKS DISPOSABLE ALK TUBING | Blade Works, Inc. | 1999-12-28 | 67 | 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