Cleared Traditional

K914702 - STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS (FDA 510(k) Clearance)

Class I General Hospital device.

K914702 · Depuy, Inc. · General Hospital
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Jan 1993
Decision
469d
Days
Class 1
Risk

K914702 is an FDA 510(k) clearance for the STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS. Classified as Cover, Shoe, Operating-room (product code FXP), Class I - General Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 29, 1993 after a review of 469 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Depuy, Inc. devices

Submission Details

510(k) Number K914702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1991
Decision Date January 29, 1993
Days to Decision 469 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
341d slower than avg
Panel avg: 128d · This submission: 469d
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.