Cleared Traditional

K871403 - MODIFIED C.P.R. MICROSHIELD (FDA 510(k) Clearance)

Class I Anesthesiology device.

K871403 · Westmark Enterprises, Inc. · Anesthesiology device
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May 1987
Decision
26d
Days
Class 1
Risk

K871403 is an FDA 510(k) clearance for the MODIFIED C.P.R. MICROSHIELD. 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 May 4, 1987 after a review of 26 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 K871403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1987
Decision Date May 04, 1987
Days to Decision 26 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 139d · This submission: 26d
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.