Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eaton Medical Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
167 daysmedian FDA review time
253 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931718 | SPIRIT SHIELD | Eaton Medical Corp. | 1993-09-20 | 167 | 0 |
| K921882 | THE CLEANER ACCESSORY | Eaton Medical Corp. | 1992-08-25 | 126 | 0 |
| K904824 | EASY EYES TM CONTACT LENS CLEANING MACHINE | Eaton Medical Corp. | 1991-07-05 | 253 | 0 |
| K871741 | EASY EYES TM LENS CARRYING CASE | Eaton Medical Corp. | 1987-07-22 | 78 | 0 |
| K841881 | EASY EYES TM LENS CARRYING CASE | Eaton Medical Corp. | 1984-12-03 | 210 | 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