Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ihara Medics U.S., Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
117 daysmedian FDA review time
289 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953452 | KETOREX C SANWA | Ihara Medics U.S., Inc. | 1996-05-02 | 289 | 0 |
| K912373 | KETO-340 II | Ihara Medics U.S., Inc. | 1991-07-01 | 33 | 0 |
| K903365 | KETOREX SANWA STANDARDS | Ihara Medics U.S., Inc. | 1990-12-20 | 147 | 0 |
| K903367 | KETONE TEST A SANWA STANDARD | Ihara Medics U.S., Inc. | 1990-11-20 | 117 | 0 |
| K903366 | KETONE TEST B SANWA STANDARD | Ihara Medics U.S., Inc. | 1990-11-20 | 117 | 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