# K972493: Nipro Disposable Solution Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corp.
- Decided: Sep 18, 1997 after 77 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K926448 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926448: I.V. Administration Set, Gainor Medical Europe, Ltd. (1994) Summary page 1.
- (no number) Medisystems Dialysis Priming Set: named in the summary without a submission number

## Indications for use
The Solution Infusion Sets are intended to be used for the administration of intravenous fluid solution into the body. They are also intended for use in administering intravenous fluids to a dialysis set in conjunction with hemodialysis.

Source page: https://510kreport.com/device/K972493
Methodology: https://510kreport.com/methodology