Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Charles L. Rose and Co., Inc. · 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) |
|---|---|---|---|---|---|
| K913244 | KTP/532 & KTP/YAG SURGICAL LASERS | Charles L. Rose and Co., Inc. | 1992-07-28 | 372 | 0 |
| K914922 | UNISURGE TISSUE COLLECTION SYSTEM FOR ENDOS SURG | Charles L. Rose and Co., Inc. | 1992-03-26 | 143 | 0 |
| K904248 | MODEL GLASE 210 HOLMIUM LASER SYSTEM | Charles L. Rose and Co., Inc. | 1990-12-14 | 88 | 0 |
| K903849 | MODEL RD-1200 RUBY LASER SYSTEM | Charles L. Rose and Co., Inc. | 1990-09-05 | 15 | 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