Cleared Traditional

K934790 - SEPP ADHESIVE REMOVER

K934790 is an FDA 510(k) clearance for SEPP ADHESIVE REMOVER, manufactured by Medi-Flex Hospital Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KOX cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K934790 · Medi-Flex Hospital Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
157d
Days
Class 1
Risk

K934790 is an FDA 510(k) clearance for the SEPP ADHESIVE REMOVER. Classified as Solvent, Adhesive Tape (product code KOX), Class I - General Controls.

Submitted by Medi-Flex Hospital Products, Inc. (Overland Park, US). The FDA issued a Cleared decision on March 11, 1994 after a review of 157 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4730 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Medi-Flex Hospital Products, Inc. devices

FDA 510(k) Submission Details - K934790

510(k) Number K934790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1993
Decision Date March 11, 1994
Days to Decision 157 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 115d · This submission: 157d
Pathway characteristics
Predicate-based equivalence.

KOX Device Classification - Class 1, General Controls

Product Code KOX Solvent, Adhesive Tape
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4730
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.

Regulatory Peers - KOX Solvent, Adhesive Tape

Devices cleared under the same product code (KOX) and FDA review panel - the closest regulatory comparables to K934790.
ALLKARE(TM) ADHESIVE REMOVER WIPE
K924976 · Convatec, A Division of E.R. Squibb & Sons · Apr 1993
3M REMOVER LOTION PRODUCT NUMBER 86XX
K925618 · 3M Health Care, Ltd. · Mar 1993
SKIN SUPPORT PREP PAD
K923351 · Coloplast Corp. · Sep 1992
REMOVE ADHESIVE REMOVER
K915150 · Smith & Nephew United, Inc. · Jan 1992
REMOVE ADHESIVE REMOVER
K893603 · Smith & Nephew United, Inc. · Jul 1989
ADHESIVE REMOVER
K821162 · The Healthcare Group Laboratories, Inc. · May 1982