# K093388: Smart Capnoline Guardian

- Pathway: 510(k) (Traditional)
- Applicant: Oridion Medical 1987, Ltd.
- Decided: Mar 4, 2010 after 125 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K171765: Nihon Kohden CO2 Monitor (2017), 0 descendants of its own

## Recalls of this device
- Feb 16, 2012 · Not classified · Z-1334-2012: CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.

## Indications for use
The Smart CapnoLine Guardian TM is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 60 fr. bite block, during upper endoscopy type procedures. The set is intended for single patient use only.

Source page: https://510kreport.com/device/K093388
Methodology: https://510kreport.com/methodology