Cleared Traditional

K871615 - U. V. GERMICIDAL UNIT

K871615 is an FDA 510(k) clearance for U. V. GERMICIDAL UNIT, manufactured by Lorvic Corp.. The device is a Class 2 General Hospital device with product code KMH cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K871615 · Lorvic Corp. · General Hospital
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Sep 1987
Decision
137d
Days
Class 2
Risk

K871615 is an FDA 510(k) clearance for the U. V. GERMICIDAL UNIT. Classified as Sterilizer, Dry Heat (product code KMH), Class II - Special Controls.

Submitted by Lorvic Corp. (St. Louis, US). The FDA issued a Cleared decision on September 11, 1987 after a review of 137 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 Lorvic Corp. devices

FDA 510(k) Submission Details - K871615

510(k) Number K871615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1987
Decision Date September 11, 1987
Days to Decision 137 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
8d slower than avg
Panel avg: 129d · This submission: 137d
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.