# K162216: Gri-Fill Peristaltic Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Laboratorios Grifols, S.A.
- Decided: Oct 19, 2017 after 437 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- 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: 6 generations back to K903493 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152441: KIRO Set, Kiro Robotics S.L. (2015) Summary page 4.

## Indications for use
Gri-Fill Peristaltic Set fluid transfer set is an ancillary device used in conjunction with the Gri-Fill Pharmacy Compounder and ancillary Gri-Fill sets in hospital pharmacy to provide a fluid pathway through which one solution source is delivered into a final IV container. The device is not intended to be directly connected to the patient.

Source page: https://510kreport.com/device/K162216
Methodology: https://510kreport.com/methodology