Cleared Traditional

K950392 - 4-O2 PLUS (CPR) MOUTH BARRIER

K950392 is the FDA 510(k) clearance for 4-O2 PLUS (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 20-day FDA review.

K950392 · Cal West Trading Co. · Anesthesiology device
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Feb 1995
Decision
20d
Days
Class 2
Risk

K950392 is an FDA 510(k) clearance for the 4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050. 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 February 21, 1995 after a review of 20 days - a notably fast clearance 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: 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 Cal West Trading Co. devices

Submission Details

510(k) Number K950392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1995
Decision Date February 21, 1995
Days to Decision 20 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
120d faster than avg
Panel avg: 140d · This submission: 20d
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 K950392.
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