Cleared Traditional

K972187 - BOUFFANT CAP

K972187 is an FDA 510(k) clearance for BOUFFANT CAP, manufactured by American Seal Co.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K972187 · American Seal Co. · General Hospital
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Sep 1997
Decision
91d
Days
Class 2
Risk

K972187 is an FDA 510(k) clearance for the BOUFFANT CAP. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by American Seal Co. (Hayward, US). The FDA issued a Cleared decision on September 9, 1997 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all American Seal Co. devices

FDA 510(k) Submission Details - K972187

510(k) Number K972187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1997
Decision Date September 09, 1997
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KKX Drape, Surgical

All 225
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K972187.
MENTOR SUPER ABSORBENT DRAPE
K973146 · Mentor Ophthalmics, Inc. · Dec 1997
ULTRASOUND TRANSDUCER DRAPE
K970889 · Protek Medical Products, Inc. · Oct 1997
OPPORTUNITY, INC. LACERATION TRAY
K971089 · Opportunity, Inc. · Sep 1997
DRAPE, SURGICAL-LATEX
K970891 · Protek Medical Products, Inc. · Aug 1997
SURGICAL DRAPES
K971159 · International Medsurg Connection · Jun 1997
CONVERTORS SMS DRAPES
K970554 · Allegiance Healthcare Corp. · May 1997