Cleared Traditional

Dillard Nasal Balloon Catheter (K181546) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K181546 · Intuit Medical Products, LLC · Ear, Nose, Throat device
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Jan 2020
Decision
570d
Days
Class 1
Risk

K181546 is an FDA 510(k) clearance for the Dillard Nasal Balloon Catheter. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Intuit Medical Products, LLC (Sugar Hill, US). The FDA issued a Cleared decision on January 3, 2020 after a review of 570 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Intuit Medical Products, LLC devices

Submission Details

510(k) Number K181546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2018
Decision Date January 03, 2020
Days to Decision 570 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
481d slower than avg
Panel avg: 89d · This submission: 570d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRC Instrument, Ent Manual Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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 - LRC Instrument, Ent Manual Surgical

All 64
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