# K971473: Ivalon Instrument Wipe, Ivalon Knife Cleaning Block

- Pathway: 510(k) (Traditional)
- Applicant: M-Pact Worldwide Management Corp.
- Decided: Jul 7, 1997 after 75 days
- Product code: GEC (Brush, Scrub, Operating-Room)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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 Ivaion® Instrument Wipe and PV A Khnife Cleaning Block are used to clean surgical instruments and knives.

Source page: https://510kreport.com/device/K971473
Methodology: https://510kreport.com/methodology