Cleared Traditional

K894690 - CPAP MASK

K894690 is an FDA 510(k) clearance for CPAP MASK, manufactured by Devilbiss Health Care, Inc.. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K894690 · Devilbiss Health Care, Inc. · Anesthesiology device
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Sep 1989
Decision
46d
Days
Class 2
Risk

K894690 is an FDA 510(k) clearance for the CPAP MASK. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Devilbiss Health Care, Inc. (Somerset, US). The FDA issued a Cleared decision on September 8, 1989 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5965 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Devilbiss Health Care, Inc. devices

FDA 510(k) Submission Details - K894690

510(k) Number K894690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date September 08, 1989
Days to Decision 46 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 140d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYE Device Classification - Class 2, Special Controls

Product Code BYE Attachment, Breathing, Positive End Expiratory Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5965
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 - BYE Attachment, Breathing, Positive End Expiratory Pressure

All 46
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K894690.
LIFECARE NASAL MASK KIT CAT. NO. 06-800
K894779 · Lifecare Services, Inc. · Jan 1990
C.P.A.P. VALVE AND C.P.P.A. KIT
K895360 · Ballard Medical Products · Nov 1989
DEVILBISS MODEL 7351 SERIES
K894424 · Devilbiss Health Care, Inc. · Sep 1989
DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM
K893388 · Devilbiss Health Care, Inc. · Jun 1989
EDENTEC MODEL 2860 PRESSURE METER
K891540 · Edentec Corp. · Jun 1989
MODIFIED SANDERS BI-PAPEASY
K883825 · Respironics, Inc. · Dec 1988