Cleared Traditional

RAND NASAL PACKING (K963856) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K963856 · Rand Scientific Corp. · Ear, Nose, Throat device
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Oct 1996
Decision
23d
Days
Class 1
Risk

K963856 is an FDA 510(k) clearance for the RAND NASAL PACKING. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Rand Scientific Corp. (Sacramento, US). The FDA issued a Cleared decision on October 18, 1996 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4100 - the FDA ear, nose and throat 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 Rand Scientific Corp. devices

Submission Details

510(k) Number K963856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1996
Decision Date October 18, 1996
Days to Decision 23 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 89d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EMX Balloon, Epistaxis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4100
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.