# K950388: Polaris

- Pathway: 510(k) (Traditional)
- Applicant: Spegas Industries, Ltd.
- Decided: May 2, 1995 after 90 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
No predicates in its family tree.
321 later devices descend from it; 1 cites it directly.
1 of 322 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K040011: Polaris 2004 Capnograph (2004), 320 descendants of its own
- K050844: 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL (2005), 264 descendants of its own
- K060065: CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor (2006), 250 descendants of its own
- K072295: Capnostream 20 with A2 Adaptive Averaging Software (2007), 197 descendants of its own
- K082268: CAPNOSTREAM20 with Integrated Pulmonary Index (2009), 170 descendants of its own

Source page: https://510kreport.com/device/K950388
Methodology: https://510kreport.com/methodology