# K980587: IV Decanter-Flexible

- Pathway: 510(k) (Traditional)
- Applicant: Inrad
- Decided: Apr 17, 1998 after 59 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: 1 generation back to K812852 (1981). 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)
- K812852: Set for Aseptic Decanting of a Flex I.V, Dip, Inc. (1981) Summary page 1.

## Indications for use
Aseptic Decanting of fluids from flexible containers

Source page: https://510kreport.com/device/K980587
Methodology: https://510kreport.com/methodology