Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
M. Imonti and Associates Inc., · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
182 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950800 | PRO-PAK FOR OMS DIPLOMATE | M. Imonti and Associates Inc., | 1995-05-22 | 90 | 0 |
| K950799 | PRO-VIT | M. Imonti and Associates Inc., | 1995-04-28 | 66 | 0 |
| K933627 | PHACOFRAGMENTOR TIP | M. Imonti and Associates Inc., | 1994-01-25 | 182 | 0 |
| K933503 | PRO-PHACO HANDPIECE | M. Imonti and Associates Inc., | 1994-01-06 | 171 | 0 |
| K924551 | ENDO TRACHEA TUBE FIXATION | M. Imonti and Associates Inc., | 1992-12-08 | 90 | 0 |
| K905766 | DRAINAGE TUBE RESTRAINT/WOUND COVER | M. Imonti and Associates Inc., | 1991-03-06 | 69 | 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