# K180902: MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly

- Pathway: 510(k) (Traditional)
- Applicant: Medipines Corporation
- Decided: Jan 11, 2019 after 280 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: 12 generations back to K962603 (1997). 38 ancestors in all.
No later device cites it as a predicate yet.
1 of 39 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K094012: CAPNOSTREAM20 with MICROMEDICO2 Module, Oridion Capnography, Inc. (2010) Summary page 4.

## Indications for use
The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices. At-rest patient measurements are obtained in a spot-check measurement session lasting approximately two minutes, using specified accessories which include a single patient use breathing gas mouthpiece, a single patient use nose clip, and a reusable pulse oximeter finger sensor. The device is indicated for use by qualified medical personnel in professional healthcare facilities on conscious and cooperative patients who are eighteen (18) years and older. The GEM is not to be utilized simultaneously with supplemental Oxygen nor with other respiratory gases or agents. The MediPines Gas Exchange Monitor (GEM) is not intended to be used as the sole basis for making diagnosis or treatment decisions related to patient gas exchange; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. It is not intended to replace arterial blood gas sampling for diagnosis or treatment purposes.

Source page: https://510kreport.com/device/K180902
Methodology: https://510kreport.com/methodology