Cleared Traditional

K210411 - PosiSep EAR Fragmentable Ear Dressing (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210411 · Hemostasis, LLC · Ear, Nose, Throat device
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May 2022
Decision
448d
Days
Class 2
Risk

K210411 is an FDA 510(k) clearance for the PosiSep EAR Fragmentable Ear Dressing. Classified as Polymer, Ear, Nose And Throat, Synthetic, Absorbable (product code NHB), Class II - Special Controls.

Submitted by Hemostasis, LLC (St. Paul, US). The FDA issued a Cleared decision on May 5, 2022 after a review of 448 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 874.3620 - 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.

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Submission Details

510(k) Number K210411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2021
Decision Date May 05, 2022
Days to Decision 448 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
359d slower than avg
Panel avg: 89d · This submission: 448d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
Definition Ear, Nose, And Throat Absorbable Synthetic Polymer Material Is A Device Material That Is Intended To Be Implanted For Use As A Space-occupying Substance In The Reconstructive Surgery Of The Head And Neck. The Device Is Shaped And Formed By The Surgeon To Conform To The Patient's Needs. This Generic Type Of Device Is Made Of Absorbable Synthetic Polymer Materials.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.