Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Misten Medical Corp. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962163 | MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL | Misten Medical Corp. | 1996-07-25 | 51 | 0 |
| K955616 | MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE | Misten Medical Corp. | 1996-01-17 | 37 | 0 |
| K955615 | MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS | Misten Medical Corp. | 1995-12-22 | 11 | 0 |
| K955613 | MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS | Misten Medical Corp. | 1995-12-22 | 11 | 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