# K964239: Combination Oximeter/Carbon Dioxide Gas Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Spegas Industries, Ltd.
- Decided: May 9, 1997 after 198 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- 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 K950387 (1995). 1 ancestor in all.
42 later devices descend from it; 7 cite it directly.
2 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950387: Gemini, Spegas Industries, Ltd. (1995) Summary page 2.

## Most influential descendants
- K024300: Microcap Plus/NPB-75 (2003), 20 descendants of its own
- K063752: Lifesense, Model LS1-9R (2007), 12 descendants of its own
- K983635: Julian Anesthesia Workstation, Model # Julian (1999), 11 descendants of its own
- K042607: Primus US (2004), 10 descendants of its own
- K092101: Reusable Pulse Oximeter Sensor, Model 8000 Series (2009), 7 descendants of its own

Source page: https://510kreport.com/device/K964239
Methodology: https://510kreport.com/methodology