Cleared Traditional

K925920 - TOTAL FACE MASK

K925920 is an FDA 510(k) clearance for TOTAL FACE MASK, manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K925920 · Respironics, Inc. · Anesthesiology device
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Jul 1993
Decision
240d
Days
Class 2
Risk

K925920 is an FDA 510(k) clearance for the TOTAL FACE MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Respironics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on July 21, 1993 after a review of 240 days - an extended review cycle.

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. Standard predicate reliance. 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. devices

FDA 510(k) Submission Details - K925920

510(k) Number K925920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1992
Decision Date July 21, 1993
Days to Decision 240 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
100d slower than avg
Panel avg: 140d · This submission: 240d
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 285
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K925920.
PURITAN-BENNETT COMPANION 320 I/E
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NASAL/ORAL MASK
K925587 · Respironics, Inc. · Sep 1993
318A RESPIRATORY SUPPORT SYSTEM
K923590 · Puritan Bennett Corp. · Apr 1993
REMSTAR WTIH RAMP AND REMOTE MODIFICATION
K920699 · Respironics, Inc. · Dec 1992
INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL
K911465 · Vital Signs, Inc. · Oct 1991