# K031022: Protec-Top, Sterident, Bento

- Pathway: 510(k) (Special)
- Applicant: Ronpak, Inc.
- Decided: Apr 14, 2003 after 14 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- 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
Ronclave43 packaging is indicated for use by health care facilities for the packaging, sterilization (by steam, chemical vapor or dry heat) and maintenance of sterility during storage of various medical items. The chemical indicator imprint is intended to allow the user to distinguish packages that have been processed from those that have not by changing its color from green to blue-gray.

Source page: https://510kreport.com/device/K031022
Methodology: https://510kreport.com/methodology