Ihara Medics U.S., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Ihara Medics U.S., Inc.” (first 1990, latest 1996), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 117 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 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 4 | 4 |
| JMK | Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase | 1 | 1 |
Review panels
Most recent Ihara Medics U.S., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953452 | KETOREX C SANWA | JMK | 1996-05-02 | 289 |
| K912373 | KETO-340 II | JIN | 1991-07-01 | 33 |
| K903365 | KETOREX SANWA STANDARDS | JIN | 1990-12-20 | 147 |
| K903367 | KETONE TEST A SANWA STANDARD | JIN | 1990-11-20 | 117 |
| K903366 | KETONE TEST B SANWA STANDARD | JIN | 1990-11-20 | 117 |
Recalls
openFDA lists no recalls under a recalling firm named Ihara Medics U.S., Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ihara Medics U.S., Inc.?
FDA lists 5 510(k) clearances under the applicant name “Ihara Medics U.S., Inc.” (first 1990, latest 1996), across 2 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 Ihara Medics U.S., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ihara Medics U.S., Inc. is 117 days.
Which FDA product codes appear under Ihara Medics U.S., Inc.?
The most frequent FDA product codes under this applicant name are JIN (Nitroprusside, Ketones (Urinary, Non-Quant.), 4); JMK (Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase, 1).
Next steps
- See all 5 Ihara Medics U.S., Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIN, Ihara Medics U.S., 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.