# K060331: Sigma Alpha Vaporizer

- Pathway: 510(k) (Traditional)
- Applicant: Penlon Limited
- Decided: May 10, 2006 after 90 days
- Product code: CAD (Vaporizer, Anesthesia, Non-Heated)
- Device class: 2
- Regulation: 21 CFR 868.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940255 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002343: Sigma Delta, Penlon, Ltd. (2001) Summary page 1.
- K000275: Datex-Ohmeda Tec 6 Plus Anesthesia Vaporizer, Datex-Ohmeda Tec 6 Plus Nad Variant Anesthesia, Datex-Ohmeda, Inc. (2000) Summary page 1.
- K042276: D-Vapor, Draeger Medical, Inc. (2004) Summary page 1.

## Indications for use
The Sigma Alpha Vaporizer vaporizes a specific anaesthetic agent - Suprane®, also know as Desfiurane - and delivers controlled concentrations of the vaporized anaesthetic agent into E fresh gas that is then breathed by the patient. The Sigma Alpha Vaporizer is indicated for use by both adult and pediatric patients. The Sigma Alpha Vaporizer is not intendedto be used with Enflurane, Halothane, IsofluranE or Sevoflurane, or for use in a breathing circuit. The Sigma Alpha Vaporizer is a restricted medical device intended for use by qualifiec trained personnel, i.e. Nurses and Technicians under the direction of a Physician. It if supplied as a prescription device, and the labeling indicates this.

Source page: https://510kreport.com/device/K060331
Methodology: https://510kreport.com/methodology