Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kamiya Tsusan Kaisha, Ltd. — 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) |
|---|---|---|---|---|---|
| K863161 | TABLE, OPERATING ROOM, HYDRAULIC | Kamiya Tsusan Kaisha, Ltd. | 1986-09-05 | 18 | 0 |
| K832341 | ARTHROSCOPE-VARIOUS MODELS FIBEROPTIC | Kamiya Tsusan Kaisha, Ltd. | 1983-10-04 | 84 | 0 |
| K832342 | ENDOSCOPIC CAMERA TV W/AUDIO | Kamiya Tsusan Kaisha, Ltd. | 1983-09-12 | 62 | 0 |
| K832340 | OPERATING ROOM TABLES HYDRAULIC | Kamiya Tsusan Kaisha, Ltd. | 1983-08-12 | 31 | 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