Cleared Traditional

K933756 - MAGNASHIELD CPR MOUTH BARRIER

K933756 is the FDA 510(k) clearance for MAGNASHIELD CPR MOUTH BARRIER by Cal West Trading Co.. It is a Class 2 Anesthesiology device (product code CBP) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K933756 · Cal West Trading Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
155d
Days
Class 2
Risk

K933756 is an FDA 510(k) clearance for the MAGNASHIELD CPR MOUTH BARRIER. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Cal West Trading Co. (Orange, US). The FDA issued a Cleared decision on January 5, 1994 after a review of 155 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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 Cal West Trading Co. devices

Submission Details

510(k) Number K933756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1993
Decision Date January 05, 1994
Days to Decision 155 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
15d slower than avg
Panel avg: 140d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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 - CBP Valve, Non-rebreathing

All 9
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K933756.
CPR Face Shield
K192285 · Firstar Healthcare Company Limited (Guangzhou) · Nov 2020
OJR215 Pressure Relief Manifold
K173770 · Fisher & Paykel Healthcare Limited · Apr 2019
PRESSURE MANIFOLD, MODEL BC 110
K040366 · Fisher &Paykel Healthcare , Ltd. · Mar 2004
RESCUE VALVE
K833748 · Respironics, Inc. · Dec 1983
WHISTLER IN-LINE PRESSURE RELEASE VALVE
K831246 · Airlife, Inc. · Jul 1983
ONE-WAY VALVE
K790151 · Airlife, Inc. · Mar 1979