Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HRG · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
294 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013151 | ASMOTOM AUTOMATED TREPHINE SYSTEM | Bkg Opthalmics USA, Inc. | 2001-12-14 | 85 | 0 |
| K981063 | AUTOMATED CORNEAL TREPHINE | Laser Center Dev. Corp. | 1998-06-23 | 92 | 0 |
| K843957 | ULTRATHIN/SP LENS | Optical Systems Intl., Inc. | 1985-07-31 | 294 | 0 |
| K841515 | SCANLAN VASCU-STATT II | Scanlan Intl., Inc. | 1984-06-05 | 54 | 0 |
| K823901 | TREPHINE BLADES-VARIOUS MODELS | Edward Weck, Inc. | 1983-01-17 | 18 | 0 |
| K791763 | (MICRO-KERATRON, MICRO DUCT TREPHINE) | Intl. Ophthalmic Industries Corp. | 1979-11-05 | 61 | 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