NIKKISO CO., LTD.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “NIKKISO CO., LTD.” (first 1981, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 267 days. Since 2017 the median was 267 days, against 200 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
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 165 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 84 |
| 2024 | 0 | — |
| 2025 | 3 | 295 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name NIKKISO CO., LTD. took a median 267 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 200 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 5 | 5 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 5 | 5 |
| FJG | Dialyzer, Parallel Flow | 1 | 1 |
Review panels
Most recent NIKKISO CO., LTD. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU | KOC | 2025-05-15 | 267 |
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) | KOC | 2025-05-15 | 295 |
| K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | KDI | 2025-05-15 | 296 |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-E | KOC | 2023-07-28 | 57 |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series | KOC | 2023-06-16 | 112 |
| K152938 | DBB-06 Hemodialysis Delivery System | KDI | 2016-03-18 | 165 |
| K091978 | DBB-06 HEMODIALYSIS DELIVERY SYSTEM | KDI | 2010-03-25 | 267 |
| K082719 | NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P | KOC | 2009-03-30 | 194 |
| K061519 | MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM | KDI | 2007-09-28 | 484 |
| K953996 | NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS | KDI | 1997-03-19 | 573 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named NIKKISO CO., LTD..
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 NIKKISO CO., LTD.?
FDA lists 11 510(k) clearances under the applicant name “NIKKISO CO., LTD.” (first 1981, latest 2025), across 3 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 NIKKISO CO., LTD.?
The median time from FDA receipt to decision across 510(k)s cleared under the name NIKKISO CO., LTD. is 267 days. Since 2017: 267 days, versus 200 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under NIKKISO CO., LTD.?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 5); KOC (Accessories, Blood Circuit, Hemodialysis, 5); FJG (Dialyzer, Parallel Flow, 1).
Next steps
- See all 11 NIKKISO CO., LTD. clearances with predicates and recalls
- Run predicate analysis for product code KDI, NIKKISO CO., LTD.'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.