Cleared Traditional

K952897 - NIOMED SHOE COVERS

K952897 is an FDA 510(k) clearance for NIOMED SHOE COVERS, manufactured by Amerasia Corp.. The device is a Class 1 General Hospital device with product code FXP cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K952897 · Amerasia Corp. · General Hospital
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Oct 1995
Decision
122d
Days
Class 1
Risk

K952897 is an FDA 510(k) clearance for the NIOMED SHOE COVERS. Classified as Cover, Shoe, Operating-room (product code FXP), Class I - General Controls.

Submitted by Amerasia Corp. (Baldwin Park, US). The FDA issued a Cleared decision on October 23, 1995 after a review of 122 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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 Amerasia Corp. devices

FDA 510(k) Submission Details - K952897

510(k) Number K952897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1995
Decision Date October 23, 1995
Days to Decision 122 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
7d faster than avg
Panel avg: 129d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

FXP Device Classification - Class 1, General Controls

Product Code FXP Cover, Shoe, Operating-room
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 - FXP Cover, Shoe, Operating-room

All 22
Devices cleared under the same product code (FXP) and FDA review panel - the closest regulatory comparables to K952897.
CONVERTORS IMPERVIOUS SHOE COVERS
K970815 · Allegiance Healthcare Corp. · Mar 1997
SHOE COVER, NON-STERILE
K961342 · Copioumed Intl., Inc. · Dec 1996
FLUID BARRIER BOOT KNEE & ANKLE-HIGH
K955835 · Instrument Makar, Inc. · Nov 1996
OREX SHOE COVERS
K943034 · Thantex Specialties, Inc. · Jan 1995
STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS
K914702 · Depuy, Inc. · Jan 1993
DISPOSABLE SHOE COVER
K894383 · American Threshold Industries, Inc. · Sep 1989