Cleared Traditional

K863359 - BOUFFANT-STYLE SURGICAL CAP

K863359 is an FDA 510(k) clearance for BOUFFANT-STYLE SURGICAL CAP, manufactured by Kimberly-Clark Corp.. The device is a Class 1 General & Plastic Surgery device with product code FYF cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K863359 · Kimberly-Clark Corp. · General & Plastic Surgery device
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Sep 1986
Decision
27d
Days
Class 1
Risk

K863359 is an FDA 510(k) clearance for the BOUFFANT-STYLE SURGICAL CAP. Classified as Cap, Surgical (product code FYF), Class I - General Controls.

Submitted by Kimberly-Clark Corp. (Roswell, US). The FDA issued a Cleared decision on September 29, 1986 after a review of 27 days - a notably fast clearance cycle.

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: 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 Kimberly-Clark Corp. devices

FDA 510(k) Submission Details - K863359

510(k) Number K863359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1986
Decision Date September 29, 1986
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
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 10
Devices cleared under the same product code (FYF) and FDA review panel - the closest regulatory comparables to K863359.
KIMBERLY-CLARK FULL COVERAGE HOOD
K875261 · Kimberly-Clark Corp. · Jan 1988
TECNOL SURGEON'S CAP
K873830 · Tecnol New Jersey Wound Care, Inc. · Oct 1987
SURGICAL CAP CALOT
K851558 · Roseburg SA · Apr 1985
BOUNDARY HEADWEAR
K831357 · Procter & Gamble Mfg. Co. · Jun 1983
DISPOSABLE SURGERY CAPS & HOODS
K810199 · Anago, Inc. · Feb 1981
DISPOSABLE NURSES CAP
K802186 · Anago, Inc. · Sep 1980