Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mitsubishi Cable America, 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) |
|---|---|---|---|---|---|
| K955717 | ENDOSCOPE INTRODUCER KIT | Mitsubishi Cable America, Inc. | 1996-04-18 | 122 | 0 |
| K960081 | BATTERY POWERED ENDOSCCOPIC LIGHT SOURCE | Mitsubishi Cable America, Inc. | 1996-03-12 | 61 | 0 |
| K936257 | ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3 | Mitsubishi Cable America, Inc. | 1994-03-24 | 84 | 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