# K010795: Capnoprobe SL, Model 2000

- Pathway: 510(k) (Special)
- Applicant: Optical Sensors, Inc.
- Decided: Apr 11, 2001 after 26 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- 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.
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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Aug 24, 2004 · Not classified · Z-1414-04: The product is contaminated with Burkholderia cepacia (formally known as Pseudomonas cepacia), based on the Texas Health Department analysis and also firm's analysis.

Source page: https://510kreport.com/device/K010795
Methodology: https://510kreport.com/methodology