Cleared Traditional

K982929 - MAXAIR NASAL DILATOR SYSTEM

K982929 is an FDA 510(k) clearance for MAXAIR NASAL DILATOR SYSTEM, manufactured by Hnl Technologies. The device is a Class 1 Ear, Nose, Throat device with product code LWF cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K982929 · Hnl Technologies · Ear, Nose, Throat device
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Sep 1998
Decision
20d
Days
Class 1
Risk

K982929 is an FDA 510(k) clearance for the MAXAIR NASAL DILATOR SYSTEM. Classified as Dilator, Nasal (product code LWF), Class I - General Controls.

Submitted by Hnl Technologies (San Mateo, US). The FDA issued a Cleared decision on September 9, 1998 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3900 - 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 Hnl Technologies devices

FDA 510(k) Submission Details - K982929

510(k) Number K982929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1998
Decision Date September 09, 1998
Days to Decision 20 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 90d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

LWF Device Classification - Class 1, General Controls

Product Code LWF Dilator, Nasal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3900
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 - LWF Dilator, Nasal

All 8
Devices cleared under the same product code (LWF) and FDA review panel - the closest regulatory comparables to K982929.
OptiPillows EPAP Mask
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INVENT SNORING DEVICE
K120665 · Ventus Medical, Inc. · Jun 2012
BREATHE FIT
K963326 · Cambridge Assoc. · Feb 1997
AIR MAX EXTERNAL NASAL DILATOR STRIP
K962400 · American White Cross, Inc. · Sep 1996
ACUTEK'S CLEARPASAGE
K962698 · Acutek Adhesive Specialties, Inc. · Sep 1996
BREATHE RIGHT NASAL STRIP
K955711 · Cns, Inc. · May 1996