Cleared Traditional

BOUFFANT CAP (K953878) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K953878 · American Threshold Industries, Inc. · General & Plastic Surgery device
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Jan 1996
Decision
142d
Days
Class 1
Risk

K953878 is an FDA 510(k) clearance for the BOUFFANT CAP. Classified as Cap, Surgical (product code FYF), Class I - General Controls.

Submitted by American Threshold Industries, Inc. (Enka, US). The FDA issued a Cleared decision on January 5, 1996 after a review of 142 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4040 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all American Threshold Industries, Inc. devices

Submission Details

510(k) Number K953878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1995
Decision Date January 05, 1996
Days to Decision 142 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 115d · This submission: 142d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FYF Cap, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
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.