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
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 Peers - BSJ Mask, Gas, Anesthetic

All 22
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
AMBU DISPOSABLE FACE MASK
K932014 · Ambu, Inc. · Jun 1993
RESPIRONICS SEALEASY II
K890795 · Respironics, Inc. · Apr 1989
MODIFIED CUSHION-FLEX(TM)
K890108 · Life Design Systems, Inc. · Jan 1989
CUSHION FLEX(TM)
K884387 · Life Design Systems, Inc. · Nov 1988
MP-XMM DISPOSABLE FACE MASK
K862781 · Medipart Jerry Alexander · Aug 1986