Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Takagi Seiko Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
127 daysmedian FDA review time
265 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182491 | Applanation tonometer AT-2 | Takagi Seiko Co., Ltd. | 2018-12-10 | 90 | 0 |
| K172728 | Applanation tonometer AT-1 | Takagi Seiko Co., Ltd. | 2017-10-17 | 36 | 0 |
| K162636 | Marco Ultra M3, Marco Ultra M4 | Takagi Seiko Co., Ltd. | 2017-04-14 | 205 | 0 |
| K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscope | Takagi Seiko Co., Ltd. | 2016-05-26 | 265 | 0 |
| K063352 | ELLEX SLIT LAMP, MODEL 30XL | Takagi Seiko Co., Ltd. | 2007-03-13 | 127 | 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