Cleared Traditional

PRIMED SHOE COVERS, PRIMED HEAD COVERS (K971076) - FDA 510(k) Clearance

Class I General Hospital device.

K971076 · Primeline Medical Products, Inc. · General Hospital
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Jan 1998
Decision
295d
Days
Class 1
Risk

K971076 is an FDA 510(k) clearance for the PRIMED SHOE COVERS, PRIMED HEAD COVERS. Classified as Cover, Shoe, Operating-room (product code FXP), Class I - General Controls.

Submitted by Primeline Medical Products, Inc. (Alberta, CA). The FDA issued a Cleared decision on January 13, 1998 after a review of 295 days - an extended review cycle.

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 Primeline Medical Products, Inc. devices

Submission Details

510(k) Number K971076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1997
Decision Date January 13, 1998
Days to Decision 295 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
166d slower than avg
Panel avg: 129d · This submission: 295d
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.