# K013401: K-Systems Culture Bag Sealer and Culture Bags Type CBS-1 and CB-01

- Pathway: 510(k) (Traditional)
- Applicant: K-Systems, Kivex Biotec, Ltd.
- Decided: Dec 14, 2001 after 60 days
- Product code: MQG (Accessory, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6120
- 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 K-Systems Culture bag system is intended for use during Assisted Reproduction Technology (ART). The K-SYSTEMS Culture Bag System is a device for storing culture dishes (with embryos and gametes) and to provide a stable CO, and pH micronenvironment. The K-Systems Culture Bag Sealer is a bench top device which inflates the K-Systems Culture Bags with correct gas mixture and which seals the K-Systems Culture Bags. The K-Systems Culture Bags are specially designed Culture Bags which have low penetration value for Oxygen and CO, and which are flexible and transparent making it possible to evaluate the cells within the culture bag. When the K-Systems Culture Bags have been filled with the appropriate gas mixture the K-Systems Culture Bags are placed in a conventional incubator for maintaining the temperature. The K-Systems culture bag sytem is a closed system that reduces the risk of cross contamination within the incubator.

Source page: https://510kreport.com/device/K013401
Methodology: https://510kreport.com/methodology