Cleared Traditional

K101689 - EMM EQUIPMENT COVER-POLYTHYLENE

K101689 is an FDA 510(k) clearance for EMM EQUIPMENT COVER-POLYTHYLENE, manufactured by Exact Medical Manufacturing, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K101689 · Exact Medical Manufacturing, Inc. · General Hospital
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Sep 2010
Decision
96d
Days
Class 2
Risk

K101689 is an FDA 510(k) clearance for the EMM EQUIPMENT COVER-POLYTHYLENE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Exact Medical Manufacturing, Inc. (Buffalo, US). The FDA issued a Cleared decision on September 20, 2010 after a review of 96 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 Exact Medical Manufacturing, Inc. devices

FDA 510(k) Submission Details - K101689

510(k) Number K101689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2010
Decision Date September 20, 2010
Days to Decision 96 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
33d faster than avg
Panel avg: 129d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KKX Drape, Surgical

All 215
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