Nitto Denko America, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Nitto Denko America, Inc.” (first 1985, latest 1987), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 16 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | 4 | 4 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
Review panels
Most recent Nitto Denko America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K871441 | ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE | DRX | 1987-08-03 | 112 |
| K853647 | NITTO SURGICAL PAPER TAPE ST-310 | KGX | 1985-09-19 | 16 |
| K853646 | NITTO SURGICAL NON-WOVEN TAPE ST-320 | KGX | 1985-09-19 | 16 |
| K853645 | NITTO SURGICAL CLOTH TAPE ST-330 | KGX | 1985-09-19 | 16 |
| K853644 | NITTO SURGICAL PLASTIC TAPE ST-356 | KGX | 1985-09-19 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Nitto Denko America, 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.
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.
- Nitto Denko Technical Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nitto Denko America, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Nitto Denko America, Inc.” (first 1985, latest 1987), across 2 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 Nitto Denko America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nitto Denko America, Inc. is 16 days.
Which FDA product codes appear under Nitto Denko America, Inc.?
The most frequent FDA product codes under this applicant name are KGX (Tape And Bandage, Adhesive, 4); DRX (Electrode, Electrocardiograph, 1).
Next steps
- See all 5 Nitto Denko America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGX, Nitto Denko 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.