Cleared Traditional

K860780 - PLASTIC MOUTH BARRIER HCV-E

K860780 is the FDA 510(k) clearance for PLASTIC MOUTH BARRIER HCV-E by Westmark Enterprises, Inc.. It is a Class 1 Anesthesiology device (product code CAE) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K860780 · Westmark Enterprises, Inc. · Anesthesiology device
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Apr 1986
Decision
30d
Days
Class 1
Risk

K860780 is an FDA 510(k) clearance for the PLASTIC MOUTH BARRIER HCV-E. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by Westmark Enterprises, Inc. (Skokie, US). The FDA issued a Cleared decision on April 2, 1986 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5110 - 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 Westmark Enterprises, Inc. devices

Submission Details

510(k) Number K860780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1986
Decision Date April 02, 1986
Days to Decision 30 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAE Airway, Oropharyngeal, Anesthesiology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5110
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.