Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ast Products, 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) |
|---|---|---|---|---|---|
| K200057 | bioli lOL Delivery System | Ast Products, Inc. | 2020-06-04 | 143 | 0 |
| K182965 | BL-Cart IOL Delivery Cartridge | Ast Products, Inc. | 2019-03-29 | 155 | 0 |
| K172228 | pioli IOL Delivery System | Ast Products, Inc. | 2017-12-15 | 143 | 0 |
| K142056 | LIOLI IOL DELIVERY SYSTEM | Ast Products, Inc. | 2015-04-09 | 254 | 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