Cleared Traditional

K854726 - MEDI-WIPES UNITED ANTISEPTIC SKIN PREP (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K854726 · Pfizer, Inc. · Gastroenterology & Urology device
Feb 1986
Decision
91d
Days
Class 1
Risk

K854726 is an FDA 510(k) clearance for the MEDI-WIPES UNITED ANTISEPTIC SKIN PREP. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Pfizer, Inc. (Ny, US). The FDA issued a Cleared decision on February 24, 1986 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5900 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K854726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1985
Decision Date February 24, 1986
Days to Decision 91 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 156d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EXB Collector, Ostomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5900
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.