# K973238: Zefon Adult Anesthesia Breathing Circuit with Filter, Zefon Pediatric Anesthesia Breathing Circuit with Filter

- Pathway: 510(k) (Traditional)
- Applicant: Bill Olson Corp.
- Decided: Mar 11, 1998 after 195 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- 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 Zefon Anesthesia Circuit with Bacterial Filter is intended for use in the administration of medical gases during anesthesia. The circuit connects the anesthesia gas machine to the patient by means of an oronasal face mask or by a connection to an artificial airway, such as an endotracheal tube. In the case of the Zefon circuit, a heat moisture exchange filter is included to minimize viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit.

Source page: https://510kreport.com/device/K973238
Methodology: https://510kreport.com/methodology