Cleared Traditional

K872319 - LN 100 BREAST MARKER (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K872319 · Instrumentation Industries, Inc. · General & Plastic Surgery device
Aug 1987
Decision
55d
Days
Class 1
Risk

K872319 is an FDA 510(k) clearance for the LN 100 BREAST MARKER. Classified as Tape, Measuring, Rulers And Calipers (product code FTY), Class I - General Controls.

Submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on August 11, 1987 after a review of 55 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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.

Submission Details

510(k) Number K872319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1987
Decision Date August 11, 1987
Days to Decision 55 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 132d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FTY Tape, Measuring, Rulers And Calipers
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.