# K974621: Percupump II with Eda

- Pathway: 510(k) (Traditional)
- Applicant: E-Z-Em, Inc.
- Decided: Jan 27, 1998 after 47 days
- Product code: DSB (Plethysmograph, Impedance)
- Device class: 2
- Regulation: 21 CFR 870.2770
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The device is indicated for the administration of ionic and nonionic compounds in conjunction with computed tomography scanning of the body. The extravasation detecting electrode patch element of the device is indicated for contact with intact skin and single use only.

Source page: https://510kreport.com/device/K974621
Methodology: https://510kreport.com/methodology