Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FWC · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K890119 | BR-S601MU (SURGICAL VIDEO RECORDER) | Victor Co. of Japan, Ltd. C/O Jvc Corp. | 1989-01-24 | 13 | 0 |
| K864381 | LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM | Luxtec Corp. | 1986-12-09 | 34 | 0 |
| K854988 | KY-M280U SURGICAL CAMERA | Us Jvc Corp. | 1986-01-24 | 43 | 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