510(k) · Cleared
ClearedSuperNO2VA Et Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Revolutionary Medical Devices, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Jun 20, 2018 as substantially equivalent to K011050 (Oridion Medical 1987, Ltd., 2001) and 1 other predicate after a 264-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jun 20, 2018
- Review
- 264 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K953107 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953107 | Anesthesia/Respiratory Face Mask | Medical Marketing Concepts | 1995 | — |
| −1 | K163277 | SuperNO2VA Device | Revolutionary Medical Devices, Inc. | 2017 | — |
| 0 (this device) | K173147 | SuperNO2VA Et Device | Revolutionary Medical Devices, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 CCK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CCK device
- #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K011050 | Microstream Oral Nasal Cannula FilterlineSummary page 4…ous-phase 21CFR 868.1400, Class 2 Device: SuperNO2VA Et™ Device Predicate Devices: Primary - K011050 – Oridion Microstream (CapnoLine) - CCK Secondary – K163277 – RMD – SuperNO2VA™ Device - BSJ R… | 2001 |
| * | K163277 | SuperNO2VA Device Cleared while this submission was under review Summary page 4…SuperNO2VA Et™ Device Predicate Devices: Primary - K011050 – Oridion Microstream (CapnoLine) - CCK Secondary – K163277 – RMD – SuperNO2VA™ Device - BSJ Reference Devices: Class 510(k) exempt - Medline – Anesthesia Face Mask… | 2017 |
| † | K133806 | M1 Capnography Mask | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 22.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K011050.
How does its category compare?
All CCK devicesCCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · CCK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCK
169in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CCK
1in 2022
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · CCK
1,259in 2025
MAUDE reports naming product code CCK, 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 | 5 | 56 | 0 | 7 |
| 2008 | 3 | 248 | 1 | 20 |
| 2009 | 3 | 101 | 19 | 21 |
| 2010 | 3 | 125 | 4 | 12 |
| 2011 | 2 | — | 14 | 18 |
| 2012 | 7 | 150 | 3 | 13 |
| 2013 | 4 | 132 | 2 (1) | 28 |
| 2014 | 9 | 166 | 0 | 51 |
| 2015 | 5 | 105 | 1 | 114 |
| 2016 | 2 | — | 0 | 88 |
| 2017 | 5 | 134 | 0 | 58 |
| 2018 | 6 | 296 | 5 | 63 |
| 2019 | 7 | 261 | 7 (7) | 141 |
| 2020 | 4 | 188 | 1 | 2,302 |
| 2021 | 4 | 227 | 0 | 2,272 |
| 2022 | 3 | 226 | 1 | 2,475 |
| 2023 | 4 | 555 | 0 | 1,637 |
| 2024 | 3 | 592 | 0 | 1,216 |
| 2025 | 3 | 169 | 0 | 1,259 |
| 2026 | 3 | 224 | 0 | — |
What is it indicated for?
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…
Read the full statement (115 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173147: SuperNO2VA Et Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173147
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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