Cleared Traditional

K945472 - WESTMED PEDIATRIC AND ADULT AEROSOL MASK

K945472 is an FDA 510(k) clearance for WESTMED PEDIATRIC AND ADULT AEROSOL MASK, manufactured by Westmed Intl.. The device is a Class 1 Anesthesiology device with product code BYG cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K945472 · Westmed Intl. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
91d
Days
Class 1
Risk

K945472 is an FDA 510(k) clearance for the WESTMED PEDIATRIC AND ADULT AEROSOL MASK. Classified as Mask, Oxygen (product code BYG), Class I - General Controls.

Submitted by Westmed Intl. (Tucson, US). The FDA issued a Cleared decision on February 7, 1995 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5580 - 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 Westmed Intl. devices

FDA 510(k) Submission Details - K945472

510(k) Number K945472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1994
Decision Date February 07, 1995
Days to Decision 91 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
49d faster than avg
Panel avg: 140d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

BYG Device Classification - Class 1, General Controls

Product Code BYG Mask, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5580
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 - BYG Mask, Oxygen

All 25
Devices cleared under the same product code (BYG) and FDA review panel - the closest regulatory comparables to K945472.
FIRST AID KIT(S)
K963298 · Vector, Inc. · Nov 1996
HANS RUDOLPH NASAL CPAP MASK
K962848 · Hans Rudolph, Inc. · Oct 1996
SEAL RING FOR NASAL CPAP
K921499 · Devilbiss Health Care, Inc. · Sep 1992
TRACHEOSTOMY MASK
K913501 · B & F Medical Products, Inc. · Jan 1992
SALTER LABS INFANT MEDIUM CONCENTRATION MASK
K912633 · Salter Labs · Jul 1991
SLEEPAP MASK
K894642 · Medical Industries America, Inc. · Oct 1989