Cleared Traditional

K983276 - HYDROFERA BACTERISTATIC NASAL DRESSING

K983276 is an FDA 510(k) clearance for HYDROFERA BACTERISTATIC NASAL DRESSING, manufactured by Hydrofera, LLC. The device is a Class 1 Ear, Nose, Throat device with product code EMX cleared through the Traditional 510(k) pathway after a 362-day FDA review.

K983276 · Hydrofera, LLC · Ear, Nose, Throat device
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Sep 1999
Decision
362d
Days
Class 1
Risk

K983276 is an FDA 510(k) clearance for the HYDROFERA BACTERISTATIC NASAL DRESSING. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Hydrofera, LLC (Willimantic, US). The FDA issued a Cleared decision on September 14, 1999 after a review of 362 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 874.4100 - 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. Elevated predicate reliance profile. 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 Hydrofera, LLC devices

FDA 510(k) Submission Details - K983276

510(k) Number K983276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1998
Decision Date September 14, 1999
Days to Decision 362 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
273d slower than avg
Panel avg: 89d · This submission: 362d
Pathway characteristics
Predicate-based equivalence.

EMX Device Classification - Class 1, General Controls

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.

Regulatory Peers - EMX Balloon, Epistaxis

All 13
Devices cleared under the same product code (EMX) and FDA review panel - the closest regulatory comparables to K983276.
PosiSep X BAM Hemostat Dressing/Intranasal Splint
K220326 · Hemostasis, LLC · Nov 2022
MEROGEL NASAL DRESSING AND SINUS STENT
K982731 · Xomed, Inc. · Feb 1999
RHINOCELL NASAL PACKINGS
K972459 · Boston Medical Products, Inc. · Aug 1997
POST-STOP EPISTAXIS CATHETER
K972078 · Boston Medical Products, Inc. · Jul 1997
EPI-MAX EPISTAXIS CATHETER
K972076 · Boston Medical Products, Inc. · Jun 1997
EPI-STOP EPISTAXIS CATHETER
K972077 · Boston Medical Products, Inc. · Jun 1997