Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Koken Mfg Company, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
25 daysmedian FDA review time
32 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K864501 | KOKEN'S NEW MODEL M-3000 POWER TABLE | Koken Mfg Company, Inc. | 1986-12-16 | 32 | 0 |
| K864494 | MODEL 6500 OPTHALMIC CHAIR | Koken Mfg Company, Inc. | 1986-12-15 | 31 | 0 |
| K864574 | MAC 150E OPTHALMIC CHAIR | Koken Mfg Company, Inc. | 1986-12-15 | 25 | 0 |
| K864295 | DR.500O OPERATING TABLE | Koken Mfg Company, Inc. | 1986-11-19 | 19 | 0 |
| K864325 | DR7700 OPERATING TABLE | Koken Mfg Company, Inc. | 1986-11-19 | 16 | 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