Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Mizuho USA, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
93 daysmedian FDA review time
186 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K060825 | MULTI-USE ELECTRONIC PREGNANCY TEST | Mizuho USA, Inc. | 2006-06-19 | 84 | 1 |
| K043231 | PROOF POSITIVE ELECTRONIC PREGNANCY TEST | Mizuho USA, Inc. | 2005-04-25 | 154 | 0 |
| K000844 | ABSOLUTE HCG PREGNANCY TEST | Mizuho USA, Inc. | 2000-06-16 | 93 | 0 |
| K964002 | NATURALE HCG PREGNANCY TES | Mizuho USA, Inc. | 1996-11-07 | 31 | 0 |
| K943859 | QUICK CHECKER HCG PREGNANCY TEST | Mizuho USA, Inc. | 1995-02-10 | 186 | 0 |
| K945568 | HCG MIDSTREAM PREGNANCY TEST | Mizuho USA, Inc. | 1995-01-17 | 68 | 0 |
| K931997 | HCG MIDSTREAM PREGNANCY TEST | Mizuho USA, Inc. | 1993-09-10 | 140 | 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