Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mizuho America, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
316 daysmedian FDA review time
399 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221524 | Sugita AVM Microclip Applier | Mizuho America, Inc. | 2022-06-24 | 29 | 0 |
| K211183 | Sugita AVM Microclips | Mizuho America, Inc. | 2022-03-02 | 316 | 0 |
| K990202 | SUGITA TITANIUM ANEURYSM CLIP | Mizuho America, Inc. | 1999-06-04 | 134 | 2 |
| K960037 | SUGITA AVM MICROCLIP | Mizuho America, Inc. | 1997-02-05 | 399 | 0 |
| K955012 | MIZUHO RADIOLUCENT HEAD FRAME | Mizuho America, Inc. | 1996-09-12 | 316 | 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