# K033503: RFS Vacuum Gauge Scavenging Circuit

- Pathway: 510(k) (Special)
- Applicant: Accutron, Inc.
- Decided: Mar 12, 2004 after 128 days
- Product code: CBN (Apparatus, Gas-Scavenging)
- Device class: 2
- Regulation: 21 CFR 868.5430
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K965239 (1997). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965239: Pip Low Profile Scavenging System (260 and 261)/Universal Low Profile Scavenging System (260-U and 261-U), Accutron, Inc. (1997) Summary page 2.

## Most influential descendants
- K033028: Anefin, Model 100 (2005), 1 descendant of its own
- K092031: Vapor-Clear, Model 100 (2010), 0 descendants of its own

## Indications for use
To be used in nitrous oxide/oxygen sedation systems for the delivery to a patient a mixture of nitrous oxide and oxygen gases, for the removal from the treatment location of gases expired by the patient, and removal from the treatment location any excess gases delivered to a patient.

Source page: https://510kreport.com/device/K033503
Methodology: https://510kreport.com/methodology