Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orbusneich Medical, 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) |
|---|---|---|---|---|---|
| K163114 | Sapphire II PRO | Orbusneich Medical, Inc. | 2017-01-05 | 59 | 0 |
| K162209 | Sapphire NC Plus | Orbusneich Medical, Inc. | 2016-10-06 | 62 | 0 |
| K103808 | SAPPHIRE NC | Orbusneich Medical, Inc. | 2011-09-01 | 246 | 0 |
| K103657 | SAPPHIRE | Orbusneich Medical, Inc. | 2011-08-09 | 237 | 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