Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Optisurgical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
151 daysmedian FDA review time
185 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101561 | TX1 TISSUE REMOVAL SYSTEM | American Optisurgical, Inc. | 2010-08-27 | 84 | 2 |
| K080803 | VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551 | American Optisurgical, Inc. | 2008-09-22 | 185 | 0 |
| K020527 | HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 | American Optisurgical, Inc. | 2002-07-09 | 140 | 1 |
| K953538 | RM001 REUSABLE | American Optisurgical, Inc. | 1995-12-26 | 151 | 0 |
| K953539 | DM001 DISPOSABLE PACK | American Optisurgical, Inc. | 1995-12-26 | 151 | 0 |
| K952331 | AOI LC-40 PHACOEMULSIFIER | American Optisurgical, Inc. | 1995-08-16 | 90 | 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