Cleared Traditional

SCANLAN (TM) INSTRUMENT TRAY (K864920) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K864920 · Scanlan Intl., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
27d
Days
Class 1
Risk

K864920 is an FDA 510(k) clearance for the SCANLAN (TM) INSTRUMENT TRAY. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by Scanlan Intl., Inc. (Saint Paul, US). The FDA issued a Cleared decision on January 12, 1987 after a review of 27 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.

View all Scanlan Intl., Inc. devices

Submission Details

510(k) Number K864920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1986
Decision Date January 12, 1987
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FSM Tray, Surgical, Instrument
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.