Cleared Traditional

K831372 - TLS SURGICAL MARKER

K831372 is an FDA 510(k) clearance for TLS SURGICAL MARKER, manufactured by Porex Medical. The device is a Class 1 General & Plastic Surgery device with product code FZZ cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K831372 · Porex Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
58d
Days
Class 1
Risk

K831372 is an FDA 510(k) clearance for the TLS SURGICAL MARKER. Classified as Marker, Skin (product code FZZ), Class I - General Controls.

Submitted by Porex Medical (Mchenry, US). The FDA issued a Cleared decision on June 24, 1983 after a review of 58 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 Porex Medical devices

FDA 510(k) Submission Details - K831372

510(k) Number K831372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1983
Decision Date June 24, 1983
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
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 12
Devices cleared under the same product code (FZZ) and FDA review panel - the closest regulatory comparables to K831372.
SCANLAN COLORMARK SKIN MARKER
K841085 · Scanlan Intl., Inc. · Jun 1984
SECURLINE SURGICAL SKIN MARKER 1000
K840820 · Precision Dynamics Corp. · Apr 1984
SURGISCRIBE MARKING PEN
K840470 · Surgicot, Inc. · Mar 1984
SKIN MARKERS
K821063 · Devon Industries, Inc. · Jun 1982
SURGICAL RULER AND PEN
K790084 · Devon Industries, Inc. · Feb 1979
SKIN MARKING PEN
K781770 · Abco Dealers, Inc. · Nov 1978