Cleared Traditional

K952606 - TARGETT PATCH

K952606 is an FDA 510(k) clearance for TARGETT PATCH, manufactured by Cutting Edge Technologies, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K952606 · Cutting Edge Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
198d
Days
Class 1
Risk

K952606 is an FDA 510(k) clearance for the TARGETT PATCH. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Cutting Edge Technologies, Inc. (Malvern, US). The FDA issued a Cleared decision on December 21, 1995 after a review of 198 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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 Cutting Edge Technologies, Inc. devices

FDA 510(k) Submission Details - K952606

510(k) Number K952606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1995
Decision Date December 21, 1995
Days to Decision 198 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 115d · This submission: 198d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - KGX Tape And Bandage, Adhesive

All 90
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K952606.
CARE BAND ANTIBACTERIAL BANDAGES
K983368 · Aso Corp. · Feb 1999
SYVEK PATCH
K972914 · Marine Polymer Technologies, Inc. · Dec 1997
ADHESIVE BANDAGES WITH OTC DRUG
K943314 · Johnson & Johnson Consumer Products, Inc. · Jan 1996
DERMIVIEW HYPOALLERGENIC CLEAR TAPE
K944587 · Johnson & Johnson Medical, Inc. · Oct 1995
STERILE PLASTIC DRESSING
K944588 · Smith & Nephew, Inc. · Nov 1994
EMPI TAPE PATCHES
K941389 · Empi · Aug 1994