Cleared Traditional

K851612 - DERMA PREP

K851612 is an FDA 510(k) clearance for DERMA PREP, manufactured by Mowbray Co., Inc.. The device is a Class 1 General Hospital device with product code KGT cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K851612 · Mowbray Co., Inc. · General Hospital
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May 1985
Decision
15d
Days
Class 1
Risk

K851612 is an FDA 510(k) clearance for the DERMA PREP. Classified as Drape, Adhesive, Aerosol (product code KGT), Class I - General Controls.

Submitted by Mowbray Co., Inc. (Waterloo, US). The FDA issued a Cleared decision on May 3, 1985 after a review of 15 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4380 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mowbray Co., Inc. devices

FDA 510(k) Submission Details - K851612

510(k) Number K851612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1985
Decision Date May 03, 1985
Days to Decision 15 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
114d faster than avg
Panel avg: 129d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

KGT Device Classification - Class 1, General Controls

Product Code KGT Drape, Adhesive, Aerosol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4380
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.