# K173147: SuperNO2VA Et Device

- Pathway: 510(k) (Traditional)
- Applicant: Revolutionary Medical Devices, Inc.
- Decided: Jun 20, 2018 after 264 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: 2 generations back to K953107 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011050: Microstream Oral Nasal Cannula Filterline, Oridion Medical 1987, Ltd. (2001) Summary page 4.
- K163277: SuperNO2VA Device, Revolutionary Medical Devices, Inc. (2017). Cleared while this submission was under review Summary page 4.

## Indications for use
The SuperNO2VA Et™ Device is a nasal mask that creates a seal when positioned over a patient’s nose to direct anesthesia gas, air, and / or oxygen to the upper airway during the continuum of anesthesia care. It has a means for sampling expired gases from the patient’s exhaled breath from the oral / nasal areas. The SuperNO2VA Et™ Device is intended for short-term (<24 hours) use on adult patients (>30 kg.). It is a single patient use, disposable. The SuperNO2VA Et™ Device is contraindicated for use in long-term ventilation conditions and treatment of sleep apnea. To be used under clinical supervision with adequate alarms and safety systems for monitoring and treatment of ventilatory failure.

Source page: https://510kreport.com/device/K173147
Methodology: https://510kreport.com/methodology