Cleared Traditional

K953878 - BOUFFANT CAP

K953878 is an FDA 510(k) clearance for BOUFFANT CAP, manufactured by American Threshold Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FYF cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K953878 · American Threshold Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K953878

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 115d · This submission: 142d
Pathway characteristics
Predicate-based equivalence.

FYF Device Classification - Class 1, General Controls

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.

Regulatory Peers - FYF Cap, Surgical

All 18
Devices cleared under the same product code (FYF) and FDA review panel - the closest regulatory comparables to K953878.
SURGICAL CAP
K954556 · Thai Disposable Products Co., Ltd. · Mar 1996
NIOMED SURGICAL HOOD
K954454 · Amerasia Corp. · Jan 1996
NIOMED BOUFFANT CAPS
K954455 · Amerasia Corp. · Jan 1996
SURGEON'S CAP
K953879 · American Threshold Industries, Inc. · Jan 1996
KIMBERLY-CLARK FULL COVERAGE HOOD
K875261 · Kimberly-Clark Corp. · Jan 1988
TECNOL SURGEON'S CAP
K873830 · Tecnol New Jersey Wound Care, Inc. · Oct 1987