# K163277: SuperNO2VA Device

- Pathway: 510(k) (Traditional)
- Applicant: Revolutionary Medical Devices, Inc.
- Decided: Oct 13, 2017 after 326 days
- Product code: BSJ (Mask, Gas, Anesthetic)
- Device class: 1
- Regulation: 21 CFR 868.5550
- 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 K953107 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953107: Anesthesia/Respiratory Face Mask, Medical Marketing Concepts (1995) Summary page 4.

## Most influential descendants
- K173147: SuperNO2VA Et Device (2018), 0 descendants of its own

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

Source page: https://510kreport.com/device/K163277
Methodology: https://510kreport.com/methodology