Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
U.S. Shizai Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
141 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853841 | HARMO SONIC | U.S. Shizai Corp. | 1986-02-04 | 141 | 0 |
| K822464 | OBTURATION GUTTA | U.S. Shizai Corp. | 1982-11-03 | 79 | 0 |
| K820639 | OBTURATION SYSTEM KIT | U.S. Shizai Corp. | 1982-04-09 | 32 | 0 |
| K802189 | DENTLOID | U.S. Shizai Corp. | 1980-09-26 | 16 | 0 |
| K800951 | CASTA-LLOY | U.S. Shizai Corp. | 1980-05-08 | 15 | 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