Cleared Traditional

K843116 - DISPOSABLE SKIN MARKING PEN

K843116 is an FDA 510(k) clearance for DISPOSABLE SKIN MARKING PEN, manufactured by E.M. Adams. The device is a Class 1 General & Plastic Surgery device with product code FZZ cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K843116 · E.M. Adams · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1984
Decision
9d
Days
Class 1
Risk

K843116 is an FDA 510(k) clearance for the DISPOSABLE SKIN MARKING PEN. Classified as Marker, Skin (product code FZZ), Class I - General Controls.

Submitted by E.M. Adams (Mchenry, US). The FDA issued a Cleared decision on August 17, 1984 after a review of 9 days - a notably fast clearance cycle.

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: 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 E.M. Adams devices

FDA 510(k) Submission Details - K843116

510(k) Number K843116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1984
Decision Date August 17, 1984
Days to Decision 9 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 115d · This submission: 9d
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

All 8
Devices cleared under the same product code (FZZ) and FDA review panel - the closest regulatory comparables to K843116.
SKIN MARKER
K905143 · Aesculap, Inc. · Feb 1991
SURGICAL SKIN MARKER
K896792 · Westmark, Sterile Packing Systems, Inc. (Sps) · Dec 1989
SECURLINE SURGICAL SKIN MARKER 1000
K844865 · Precision Dynamics Corp. · Jan 1985
SECURLINE SURGICAL SKIN MARKER 1000
K840820 · Precision Dynamics Corp. · Apr 1984
SKIN MARKERS
K821063 · Devon Industries, Inc. · Jun 1982
SURGICAL RULER AND PEN
K790084 · Devon Industries, Inc. · Feb 1979