# Nikkiso CO., LTD.

- Location (FDA's records): Shibuya-Ku, JP
- FDA decisions: 11 (1981–2025): 11 510(k) clearances
- Product codes: KDI (5), KOC (5), FJG (1)
- Predicates its devices cite: 14 (7 its own); citations of its devices by later devices: 8 (7 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Davita Clinical Research (Trri): 2 (https://510kreport.com/company/davita-clinical-research-trri)
- In-Line Diagnostics Corp.: 1 (https://510kreport.com/company/in-line-diagnostics)
- Colin Medical Instruments Corp.: 1 (https://510kreport.com/company/colin-medical-instruments)
- B. Braun Avitum AG: 1 (https://510kreport.com/company/b-braun-avitum)
- Fresenius Medical Care Renal Therapies Group, LLC: 1 (https://510kreport.com/company/fresenius-medical-care-renal-therapies-group)
- Nipro Medical Corporation: 1 (https://510kreport.com/company/nipro-medical)

## Firms that cite its devices most
- Fresenius Medical Care North America, Design Cente: 1 (https://510kreport.com/company/fresenius-medical-care-north-america-design-cente)

## Its most-cited devices
- K082719: Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P, AVO6B-P, AV06C-P (2009), cited by 3
- K230514: Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series (2023), cited by 2
- K061519: Modification to DBB-05 Hemodialysis Delivery System (2007), cited by 1
- K091978: DBB-06 Hemodialysis Delivery System (2010), cited by 1
- K152938: DBB-06 Hemodialysis Delivery System (2016), cited by 1

## Recent decisions
- 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 (May 15, 2025)
- 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) (May 15, 2025)
- K242155: DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (May 15, 2025)
- K231589: Blood Tubing Lines for Hemodialysis AV06C-E (Jul 28, 2023)
- K230514: Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series (Jun 16, 2023)
- K152938: DBB-06 Hemodialysis Delivery System (Mar 18, 2016)
- K091978: DBB-06 Hemodialysis Delivery System (Mar 25, 2010)
- K082719: Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P, AVO6B-P, AV06C-P (Mar 30, 2009)

Source page: https://510kreport.com/company/nikkiso