Nissho Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Nissho Corp.” (first 1994, latest 1997), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 91 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| FIE | Needle, Fistula | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 1 | 1 |
Review panels
Most recent Nissho Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954676 | NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS | KOC | 1997-03-04 | 511 |
| K955182 | NIPRO ARTERIAL VENOUS FISTULA NEEDLE | FIE | 1996-06-04 | 204 |
| K960051 | NIPRO SAFELET CATH | FOZ | 1996-03-28 | 84 |
| K955053 | NIPRO SCALP VEIN SET (DISPOSABL PSV SET) | FOZ | 1996-01-04 | 59 |
| K944355 | NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES | FMF | 1994-12-07 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Nissho Corp..
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.
- Nissho Iwai American Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nissho Corp.?
FDA lists 5 510(k) clearances under the applicant name “Nissho Corp.” (first 1994, latest 1997), 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 Nissho Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nissho Corp. is 91 days.
Which FDA product codes appear under Nissho Corp.?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 2); FIE (Needle, Fistula, 1); FMF (Syringe, Piston, 1).
Next steps
- See all 5 Nissho Corp. clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Nissho Corp.'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.