# K002343: Sigma Delta

- Pathway: 510(k) (Traditional)
- Applicant: Penlon, Ltd.
- Decided: Jun 8, 2001 after 311 days
- Product code: CAD (Vaporizer, Anesthesia, Non-Heated)
- Device class: 2
- Regulation: 21 CFR 868.5880
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K140264: MADM (2015), 0 descendants of its own
- K060331: Sigma Alpha Vaporizer (2006), 0 descendants of its own

## Recalls of this device
- May 14, 2013 · Class II · Z-1653-2013: It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the User Manual may not have been followed prior to the clinical use of the vaporizer. Penlon L

Source page: https://510kreport.com/device/K002343
Methodology: https://510kreport.com/methodology