Cleared Traditional

K872643 - COX RAPID HEAT TRANSFER STERILIZER

K872643 is an FDA 510(k) clearance for COX RAPID HEAT TRANSFER STERILIZER, manufactured by Cox Sterile Products, Inc.. The device is a Class 2 General Hospital device with product code KMH cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K872643 · Cox Sterile Products, Inc. · General Hospital
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Oct 1987
Decision
115d
Days
Class 2
Risk

K872643 is an FDA 510(k) clearance for the COX RAPID HEAT TRANSFER STERILIZER. Classified as Sterilizer, Dry Heat (product code KMH), Class II - Special Controls.

Submitted by Cox Sterile Products, Inc. (Dallas, US). The FDA issued a Cleared decision on October 29, 1987 after a review of 115 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6870 - 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 Cox Sterile Products, Inc. devices

FDA 510(k) Submission Details - K872643

510(k) Number K872643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1987
Decision Date October 29, 1987
Days to Decision 115 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 129d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KMH Device Classification - Class 2, Special Controls

Product Code KMH Sterilizer, Dry Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6870
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.