Cleared Traditional

K163277 - SuperNO2VA Device

K163277 is an FDA 510(k) clearance for SuperNO2VA Device, manufactured by Revolutionary Medical Devices, Inc.. The device is a Class 1 Anesthesiology device with product code BSJ cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K163277 · Revolutionary Medical Devices, Inc. · Anesthesiology device
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Oct 2017
Decision
326d
Days
Class 1
Risk

K163277 is an FDA 510(k) clearance for the SuperNO2VA Device. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Revolutionary Medical Devices, Inc. (Tucson, US). The FDA issued a Cleared decision on October 13, 2017 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5550 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Revolutionary Medical Devices, Inc. devices

FDA 510(k) Submission Details - K163277

510(k) Number K163277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2016
Decision Date October 13, 2017
Days to Decision 326 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 140d · This submission: 326d
Pathway characteristics
Predicate-based equivalence.

BSJ Device Classification - Class 1, General Controls

Product Code BSJ Mask, Gas, Anesthetic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5550
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

ProMedic, LLC
Paul Dryden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BSJ Mask, Gas, Anesthetic

All 29
Devices cleared under the same product code (BSJ) and FDA review panel - the closest regulatory comparables to K163277.
ANESTHESIA FACE MASK
K953295 · Mallinckrodt Medical · Aug 1995
AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK
K951043 · Promedic, Inc. · Jun 1995
AMBU DISPOSABLE FACE MASK
K932014 · Ambu, Inc. · Jun 1993
VENTLAB VENT-MASK, CAT# VR 0010/20/30
K903881 · Ventlab Corp. · Sep 1990
ANESTHESIA/RESPIRATORY DISPOSABLE MASK
K891316 · Concord/Portex · Aug 1989
RESPIRONICS SEALEASY II
K890795 · Respironics, Inc. · Apr 1989