Cleared Traditional

K140580 - REVOLUTION FULLFACE MASK

K140580 is an FDA 510(k) clearance for REVOLUTION FULLFACE MASK, manufactured by Respironics Inc. (Dba Philips Respironics). The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K140580 · Respironics Inc. (Dba Philips Respironics) · Anesthesiology device
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Jan 2015
Decision
316d
Days
Class 2
Risk

K140580 is an FDA 510(k) clearance for the REVOLUTION FULLFACE MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Respironics Inc. (Dba Philips Respironics) (Murrysville, US). The FDA issued a Cleared decision on January 16, 2015 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Respironics Inc. (Dba Philips Respironics) devices

FDA 510(k) Submission Details - K140580

510(k) Number K140580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2014
Decision Date January 16, 2015
Days to Decision 316 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
176d slower than avg
Panel avg: 140d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZD Ventilator, Non-continuous (respirator)

All 307
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K140580.
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K141522 · Apex Medical Corp. · Oct 2014