FIIClass II

System, Dialysate Delivery, Sealed

21 CFR 876.5860 / Gastroenterology, Urology

FII is the FDA product code for System, Dialysate Delivery, Sealed, a class II device type, regulated under 21 CFR 876.5860. As of 2026-09-10, FDA records hold 5 510(k) clearances under this code, the most recent dated 2003-07-07, and 2 recalls.

Classification record

Product code: FII
Device name: System, Dialysate Delivery, Sealed
Regulation: 21 CFR 876.5860
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 5
Ingested recalls: 2

Clearances, product code FII

By decision year

5 clearances under product code FII with a decision year between 1982 and 2003, 1982 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code FII by decision year
Year	Clearances
1982	1
1986	1
1987	1
1988	1
2003	1

Applicants with the most clearances

Product code FII

Applicants holding the most 510(k) clearances under product code FII
Applicant	Clearances
Gambro, Inc.	2
Hospal Medical Corp.	1
NxStage Medical Inc	1
Travenol Laboratories, S.A.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code FII.