Mizuho America, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Mizuho America, Inc.” (first 1996, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 316 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 172 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mizuho America, Inc. took a median 172 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HCH | Clip, Aneurysm | 3 | 3 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 1 | 1 |
| HCI | Applier, Aneurysm Clip | 1 | 1 |
Review panels
- Neurology (5)
Most recent Mizuho America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221524 | Sugita AVM Microclip Applier | HCI | 2022-06-24 | 29 |
| K211183 | Sugita AVM Microclips | HCH | 2022-03-02 | 316 |
| K990202 | SUGITA TITANIUM ANEURYSM CLIP | HCH | 1999-06-04 | 134 |
| K960037 | SUGITA AVM MICROCLIP | HCH | 1997-02-05 | 399 |
| K955012 | MIZUHO RADIOLUCENT HEAD FRAME | HBL | 1996-09-12 | 316 |
Recalls
4 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2019-09-11.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Mizuho USA, Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mizuho America, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Mizuho America, Inc.” (first 1996, latest 2022), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mizuho America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mizuho America, Inc. is 316 days.
Which FDA product codes appear under Mizuho America, Inc.?
The most frequent FDA product codes under this applicant name are HCH (Clip, Aneurysm, 3); HBL (Holder, Head, Neurosurgical (Skull Clamp), 1); HCI (Applier, Aneurysm Clip, 1).
Next steps
- See all 5 Mizuho America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HCH, Mizuho America, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.