# K092031: Vapor-Clear, Model 100

- Pathway: 510(k) (Traditional)
- Applicant: Axon Medical, Inc.
- Decided: Apr 16, 2010 after 284 days
- Product code: CBN (Apparatus, Gas-Scavenging)
- Device class: 2
- Regulation: 21 CFR 868.5430
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962603 (1997). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033028: Anefin, Model 100, Axon Medical (2005) Summary page 2.

## Recalls of this device
- May 9, 2022 · Class II · Z-1591-2023: Due to a manufacturing issue that may result in filter leakage.

## Indications for use
To remove unwanted anesthetic gases from the patient breathing circuit

Source page: https://510kreport.com/device/K092031
Methodology: https://510kreport.com/methodology