Cleared Traditional

K942246 - PURITAN-BENNETT NASAL CPAP MASK

K942246 is an FDA 510(k) clearance for PURITAN-BENNETT NASAL CPAP MASK, manufactured by Puritan-Bennett. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K942246 · Puritan-Bennett · Anesthesiology device
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Jul 1994
Decision
58d
Days
Class 2
Risk

K942246 is an FDA 510(k) clearance for the PURITAN-BENNETT NASAL CPAP MASK. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Puritan-Bennett (Lenexa, US). The FDA issued a Cleared decision on July 6, 1994 after a review of 58 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 Puritan-Bennett devices

FDA 510(k) Submission Details - K942246

510(k) Number K942246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1994
Decision Date July 06, 1994
Days to Decision 58 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 140d · This submission: 58d
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 58
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K942246.
SIMS CPAP SYSTEM
K953485 · Smiths Industries Medical Systems, Inc. · Oct 1995
KENDALL SHERIDAN CPAP SYSTEM
K953511 · Kendall Healthcare Products Co. Div.Of Tyco Health · Oct 1995
SYSTEM 22 VALVE
K950397 · Turnkey Intergration USA, Inc. · Apr 1995
SINGLE USE MANUAL RESUSCITATOR PEEP VALVE
K932799 · Engineered Medical Systems · Sep 1993
AMBU SINGLE PATIENT USE PEEP VALVE
K923976 · Ambu, Inc. · Jan 1993
COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION
K922178 · Puritan Bennett Corp. · May 1992