# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Nikkiso CO., LTD.
- Decided: May 15, 2025 after 295 days
- Product code: KOC (Accessories, Blood Circuit, Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010264 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230514: Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series, Nikkiso CO., LTD. (2023) Summary page 6.

## Indications for use
This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is not indicated for pediatric patients. It is not for home use. This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.

Source page: https://510kreport.com/device/K242176
Methodology: https://510kreport.com/methodology