Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bryan Keropian Dds · 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) |
|---|---|---|---|---|---|
| K091035 | FULL BREATH SLEEP APPLIANCE LOWER (FBSL) | Bryan Keropian Dds | 2009-06-24 | 75 | 0 |
| K061228 | FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR | Bryan Keropian Dds | 2006-05-26 | 24 | 0 |
| K053065 | FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (PO | Bryan Keropian Dds | 2006-01-03 | 63 | 0 |
| K052862 | FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) | Bryan Keropian Dds | 2005-12-30 | 80 | 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