Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IWS · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
182 daysmedian FDA review time
354 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945515 | COATED TUNGSTEN EYESHIELD | Medtec, Inc. | 1995-06-19 | 222 | 0 |
| K940119 | ROYAL MARSDEN GOLD GRAIN GUN | Best Industries | 1994-12-30 | 354 | 0 |
| K943011 | TUNGSTEN EYESHIELD | Medtec, Inc. | 1994-12-23 | 182 | 0 |
| K934459 | MED-GENESIS PATIENT LASER EYE SHIELD | Med-Genesis, Inc. | 1994-02-22 | 165 | 0 |
| K934362 | NUCLEAR ASSOCIATES GLASSERS | Victoreen, Inc. | 1993-11-12 | 65 | 0 |
| K920540 | RADIOLOGICAL PROTECTIVE EYE SHIELD | Burkhart Roentgen Intl., Inc. | 1992-05-28 | 113 | 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