Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Appasamy Associates · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110205 | AAIO-7, AAIO WIRLESS | Appasamy Associates | 2011-02-09 | 15 | 0 |
| K082031 | APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES | Appasamy Associates | 2008-07-31 | 14 | 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