Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ra Medical Systems,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) |
|---|---|---|---|---|---|
| K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DAB | Ra Medical Systems,Inc | 2022-06-29 | 124 | 0 |
| K210664 | DABRA Laser System (DABRA Laser model RA-308 and DABRA Cathe | Ra Medical Systems,Inc | 2021-07-27 | 144 | 0 |
| K170349 | RA-308 Excimer Laser System, Excimer Laser Catheter | Ra Medical Systems,Inc | 2017-05-24 | 110 | 1 |
| K062963 | PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 | Ra Medical Systems,Inc | 2007-04-03 | 186 | 2 |
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