# K013715: RE-Usable Sterilization Pouch / Bag

- Pathway: 510(k) (Traditional)
- Applicant: Quality Products of Montana
- Decided: Apr 1, 2002 after 144 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
The device is a re-usable sterilization pouch designed to complete the sterilization process and allow a simple method of packaging devices to maintain sterility. Acceptable method of sterilization is moist heat sterilization where the temperature is below 137°C (273°F). The pouch may be re-used up to 30 times in dental practices and approved for 90 days storage.

Source page: https://510kreport.com/device/K013715
Methodology: https://510kreport.com/methodology