Cleared Traditional

K841040 - FOX POST NASAL BALLOON CATHETER (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K841040 · Inmed Corp. · Ear, Nose, Throat device
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Aug 1984
Decision
158d
Days
Class 1
Risk

K841040 is an FDA 510(k) clearance for the FOX POST NASAL BALLOON CATHETER. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Inmed Corp. (Mchenry, US). The FDA issued a Cleared decision on August 17, 1984 after a review of 158 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Inmed Corp. devices

Submission Details

510(k) Number K841040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1984
Decision Date August 17, 1984
Days to Decision 158 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 89d · This submission: 158d
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.