Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tomey Corporation — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
209 daysmedian FDA review time
383 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000) | Tomey Corporation | 2025-12-18 | 142 | 0 |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) | Tomey Corporation | 2025-07-18 | 143 | 0 |
| K213265 | Tomey Cornea/Anterior Segment OCT CASIA2 | Tomey Corporation | 2022-04-27 | 209 | 0 |
| K171313 | EM-4000 Specular Microscope | Tomey Corporation | 2018-01-19 | 260 | 0 |
| K073087 | NON-CONTACT TONOMETER, MODEL FT-1000 | Tomey Corporation | 2008-11-18 | 383 | 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