Cleared Traditional

K821063 - SKIN MARKERS

K821063 is an FDA 510(k) clearance for SKIN MARKERS, manufactured by Devon Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FZZ cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K821063 · Devon Industries, Inc. · General & Plastic Surgery device
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Jun 1982
Decision
110d
Days
Class 1
Risk

K821063 is an FDA 510(k) clearance for the SKIN MARKERS. Classified as Marker, Skin (product code FZZ), Class I - General Controls.

Submitted by Devon Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1982 after a review of 110 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4660 - 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 Devon Industries, Inc. devices

FDA 510(k) Submission Details - K821063

510(k) Number K821063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1982
Decision Date June 25, 1982
Days to Decision 110 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 115d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

FZZ Device Classification - Class 1, General Controls

Product Code FZZ Marker, Skin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4660
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 - FZZ Marker, Skin

Devices cleared under the same product code (FZZ) and FDA review panel - the closest regulatory comparables to K821063.
SKIN MARKER
K905143 · Aesculap, Inc. · Feb 1991
SURGICAL SKIN MARKER
K896792 · Westmark, Sterile Packing Systems, Inc. (Sps) · Dec 1989
SURGICAL RULER AND PEN
K790084 · Devon Industries, Inc. · Feb 1979
SKIN MARKING PEN
K781770 · Abco Dealers, Inc. · Nov 1978
SURGICAL MARKING PEN
K761323 · Richard-Allan Medical Ind., Inc. · Jan 1977