Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Spectrum Medical Technologies, 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) |
|---|---|---|---|---|---|
| K963947 | EPILASER NORMAL MODE RUBY LASER | Spectrum Medical Technologies, Inc. | 1997-03-05 | 154 | 0 |
| K955612 | RD-1200H NORMAL MODE RUBY LASER SYSTEM | Spectrum Medical Technologies, Inc. | 1996-07-09 | 214 | 0 |
| K910422 | MODEL RD-1200 RUBY LASER SYSTEM | Spectrum Medical Technologies, Inc. | 1992-04-21 | 447 | 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