Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ascon Medical Instruments, Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
119 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852054 | CONTACT LENS LOUPE, INSPETION LOUPE | Ascon Medical Instruments, Ltd. | 1985-09-05 | 119 | 0 |
| K852055 | ASCON OPHTHALMIC SPONGE | Ascon Medical Instruments, Ltd. | 1985-09-04 | 118 | 0 |
| K852548 | ATL 225 MW TRAIL LENS SET | Ascon Medical Instruments, Ltd. | 1985-07-31 | 49 | 0 |
| K852057 | ASCON SURGICAL INSTRUMENTS | Ascon Medical Instruments, Ltd. | 1985-06-27 | 49 | 0 |
| K852056 | ACC CROSS CYLINDERS | Ascon Medical Instruments, Ltd. | 1985-06-05 | 27 | 0 |
| K852126 | ATF 101 TRAIL FRAME | Ascon Medical Instruments, Ltd. | 1985-06-05 | 21 | 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