KANEKA Corporation: FDA filings under this applicant name

FDA lists 11 510(k) clearances under 2 spellings of the applicant name “KANEKA Corporation” (first 2011, latest 2018), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 116 days. Since 2017 the median was 113 days, against 107 days for all cleared 510(k)s in the same product codes. 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

Review time against the same product codes

Since 2017, 510(k)s cleared under the name KANEKA Corporation took a median 113 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.

Top product codes

Review panels

• Cardiovascular (10)
• Ophthalmic (1)

Most recent KANEKA Corporation 510(k) clearances

1 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named KANEKA Corporation.

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.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under KANEKA Corporation (a text match, not an official crosswalk):

• C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)

FDA spellings included

FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:

• KANEKA Corporation (10)
• Kaneka Corp. (1)

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 Pharma America, LLC (4 510(k)s)
• Kaneka Medical America, LLC (2 510(k)s)
• Kaneka Americas Holding, Inc. (1 510(k)s)
• Kaneka Pharma America Corp. (0 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under KANEKA Corporation?

FDA lists 11 510(k) clearances under 2 spellings of the applicant name “KANEKA Corporation” (first 2011, latest 2018), across 4 product codes in 2 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 Corporation?

The median time from FDA receipt to decision across 510(k)s cleared under the name KANEKA Corporation is 116 days. Since 2017: 113 days, versus 107 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under KANEKA Corporation?

The most frequent FDA product codes under this applicant name are LIT (Catheter, Angioplasty, Peripheral, Transluminal, 6); LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous, 3); DQY (Catheter, Percutaneous, 1).

Next steps

• See all 11 KANEKA Corporation clearances with predicates and recalls
• Run predicate analysis for product code LIT, KANEKA Corporation'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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