Cleared Traditional

K163556 - MediClear PreOp

K163556 is an FDA 510(k) clearance for MediClear PreOp, manufactured by Covalontechnologies, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K163556 · Covalontechnologies, Inc. · General Hospital
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Sep 2017
Decision
269d
Days
Class 2
Risk

K163556 is an FDA 510(k) clearance for the MediClear PreOp. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Covalontechnologies, Inc. (Mississsauga, CA). The FDA issued a Cleared decision on September 14, 2017 after a review of 269 days - an extended review cycle.

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 Covalontechnologies, Inc. devices

FDA 510(k) Submission Details - K163556

510(k) Number K163556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2016
Decision Date September 14, 2017
Days to Decision 269 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
140d slower than avg
Panel avg: 129d · This submission: 269d
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 165
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K163556.
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