Cleared Traditional

K955835 - FLUID BARRIER BOOT KNEE & ANKLE-HIGH (FDA 510(k) Clearance)

Class I General Hospital device.

K955835 · Instrument Makar, Inc. · General Hospital
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 128d · This submission: 329d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.