Cleared Traditional

K955835 - FLUID BARRIER BOOT KNEE & ANKLE-HIGH

K955835 is an FDA 510(k) clearance for FLUID BARRIER BOOT KNEE & ANKLE-HIGH, manufactured by Instrument Makar, Inc.. The device is a Class 1 General Hospital device with product code FXP cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K955835 · Instrument Makar, Inc. · General Hospital
Download Printable Device Report (PDF)
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Nov 1996
Decision
329d
Days
Class 1
Risk

K955835 is an FDA 510(k) clearance for the FLUID BARRIER BOOT KNEE & ANKLE-HIGH. Classified as Cover, Shoe, Operating-room (product code FXP), Class I - General Controls.

Submitted by Instrument Makar, Inc. (Okemos, US). The FDA issued a Cleared decision on November 19, 1996 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Instrument Makar, Inc. devices

FDA 510(k) Submission Details - K955835

510(k) Number K955835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1995
Decision Date November 19, 1996
Days to Decision 329 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 129d · This submission: 329d
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 21
Devices cleared under the same product code (FXP) and FDA review panel - the closest regulatory comparables to K955835.
FAR-EAST SHOE COVERS
K971191 · Far East Science & Technology Development Co., Ltd. · Jul 1997
CONVERTORS IMPERVIOUS SHOE COVERS
K970815 · Allegiance Healthcare Corp. · Mar 1997
SHOE COVER, NON-STERILE
K961342 · Copioumed Intl., Inc. · Dec 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