510(k) · Cleared
ClearedSuperNO2VA Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Revolutionary Medical Devices, Inc. · BSJ Mask, Gas, Anesthetic
Cleared on Oct 13, 2017 as substantially equivalent to K953107 (Medical Marketing Concepts, 1995) after a 326-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Oct 13, 2017
- Review
- 326 days
- Class
- Class I
- Product code
- BSJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953107 (1995). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K173147SuperNO2VA Et DeviceRevolutionary Medical Devices, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953107 | Anesthesia/Respiratory Face Mask | Medical Marketing Concepts | 1995 | — |
| 0 (this device) | K163277 | SuperNO2VA Device | Revolutionary Medical Devices, Inc. | 2017 | — |
| +1 | K173147 | SuperNO2VA Et Device | Revolutionary Medical Devices, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BSJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K953107 | Anesthesia/Respiratory Face MaskSummary page 4…BSJ – Anesthesia face mask 21CFR 868.5550, Class 1 Device: SuperNO2VA™ Device Predicate Device: K953107 – Medical Marketing Concepts – Anesthesia / Respiratory Face Mask Device Description: The SuperN… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173147 | SuperNO2VA Et Device | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K173147 (Revolutionary Medical Devices, Inc., 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BSJ devicesBSJ Mask, Gas, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · BSJ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · BSJ
Too few BSJ 510(k)s in any year since 2007 to give a median.
Recalls per year · BSJ
1in 2011
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSJ
2in 2025
MAUDE reports naming product code BSJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 1 (1) | 1 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163277 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163277: SuperNO2VA Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163277
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026