Cleared Traditional

K922143 - AMERICAN BURN SHEET

K922143 is an FDA 510(k) clearance for AMERICAN BURN SHEET, manufactured by American Silk Sutures, Inc.. The device is a Class 1 General Hospital device with product code KME cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K922143 · American Silk Sutures, Inc. · General Hospital
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Aug 1992
Decision
96d
Days
Class 1
Risk

K922143 is an FDA 510(k) clearance for the AMERICAN BURN SHEET. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by American Silk Sutures, Inc. (Lynn, US). The FDA issued a Cleared decision on August 10, 1992 after a review of 96 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6060 - 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 Silk Sutures, Inc. devices

FDA 510(k) Submission Details - K922143

510(k) Number K922143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1992
Decision Date August 10, 1992
Days to Decision 96 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 129d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

KME Device Classification - Class 1, General Controls

Product Code KME Bedding, Disposable, Medical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6060
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 - KME Bedding, Disposable, Medical

All 26
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K922143.
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