Cleared Traditional

K973146 - MENTOR SUPER ABSORBENT DRAPE (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K973146 · Mentor Ophthalmics, Inc. · General Hospital
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Dec 1997
Decision
104d
Days
Class 2
Risk

K973146 is an FDA 510(k) clearance for the MENTOR SUPER ABSORBENT DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Mentor Ophthalmics, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on December 4, 1997 after a review of 104 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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 Mentor Ophthalmics, Inc. devices

Submission Details

510(k) Number K973146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1997
Decision Date December 04, 1997
Days to Decision 104 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
24d faster than avg
Panel avg: 128d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.