# K971624: Dye Stop and Save - Quickfill

- Pathway: 510(k) (Traditional)
- Applicant: Shepherd Laboratories, Inc.
- Decided: Sep 8, 1997 after 129 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Dye Stop and Save-Quick Fill® device is indicated as a means to administer contrast agents to a patient and to isolate a patient's bodily fluids from the contrast agent bottle to allow the use of the remaining contrast agent in the bottle on subsequent patients. It is also indicated to provide a simple means of initiation of rapid fill flow, and to exclude air from entering the tubing connecting the contrast agent chamber with a control syringe.

Source page: https://510kreport.com/device/K971624
Methodology: https://510kreport.com/methodology