Cleared Traditional

K220326 - PosiSep X BAM Hemostat Dressing/Intranasal Splint

K220326 is an FDA 510(k) clearance for PosiSep X BAM Hemostat Dressing/Intrana..., manufactured by Hemostasis, LLC. The device is a Class 1 Ear, Nose, Throat device with product code EMX cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K220326 · Hemostasis, LLC · Ear, Nose, Throat device
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Nov 2022
Decision
283d
Days
Class 1
Risk

K220326 is an FDA 510(k) clearance for the PosiSep X BAM Hemostat Dressing/Intranasal Splint. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Hemostasis, LLC (St. Paul, US). The FDA issued a Cleared decision on November 14, 2022 after a review of 283 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 Hemostasis, LLC devices

FDA 510(k) Submission Details - K220326

510(k) Number K220326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2022
Decision Date November 14, 2022
Days to Decision 283 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
193d slower than avg
Panel avg: 90d · This submission: 283d
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 31
Devices cleared under the same product code (EMX) and FDA review panel - the closest regulatory comparables to K220326.
NASALCEASE
K041446 · Les Laboratorires Brothier, S.A. · Jul 2004
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100
K000108 · Bhk Holding · May 2000
HYLASINE
K993362 · Biomatrix, Inc. · Mar 2000
HYDROFERA BACTERISTATIC NASAL DRESSING
K983276 · Hydrofera, LLC · Sep 1999
MEROGEL NASAL DRESSING AND SINUS STENT
K982731 · Xomed, Inc. · Feb 1999
ENTAXIS NASAL PACKING
K984069 · Les Laboratorires Brothier, S.A. · Jan 1999