Kaneka Pharma America, LLC: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Kaneka Pharma America, LLC” (first 2010, latest 2020), plus 1 PMA decision, across 4 product codes in 4 review panels. Median 510(k) review time under this name: 102 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 | 1 | 90 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 81 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 268 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kaneka Pharma America, LLC took a median 174 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QEZ | Aspiration Thrombectomy Catheter | 2 | 2 |
| HCG | Device, Neurovascular Embolization | 1 | 1 |
| MMY | Lipoprotein, Low Density, Removal | 1 | 0 |
| OKS | Lacrimal Stents And Intubation Sets | 1 | 1 |
Review panels
- Cardiovascular (2)
- Gastroenterology and Urology (1)
- Neurology (1)
- Ophthalmic (1)
Most recent Kaneka Pharma America, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192068 | i-ED COIL | HCG | 2020-04-25 | 268 |
| K170247 | Lacriflow CL | OKS | 2017-04-18 | 81 |
| K121301 | XPRESSWAY RX CATHETER (6F LD-VERISON) | QEZ | 2012-07-30 | 90 |
| K101839 | KANEKA PHARMA AMERICA XPRESS-WAY RX | QEZ | 2010-10-22 | 113 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P910018 | PMA | LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). | 1996-02-21 |
Recalls
openFDA lists no recalls under a recalling firm named Kaneka Pharma America, LLC.
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.
- KANEKA Corporation (11 510(k)s)
- Kaneka Medical America, LLC (2 510(k)s)
- Kaneka Americas Holding, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kaneka Pharma America, LLC?
FDA lists 4 510(k) clearances under the applicant name “Kaneka Pharma America, LLC” (first 2010, latest 2020), plus 1 PMA decision, across 4 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kaneka Pharma America, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kaneka Pharma America, LLC is 102 days.
Which FDA product codes appear under Kaneka Pharma America, LLC?
The most frequent FDA product codes under this applicant name are QEZ (Aspiration Thrombectomy Catheter, 2); HCG (Device, Neurovascular Embolization, 1); MMY (Lipoprotein, Low Density, Removal, 1).
Next steps
- See all 4 Kaneka Pharma America, LLC clearances with predicates and recalls
- Run predicate analysis for product code QEZ, Kaneka Pharma America, LLC'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.